Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01422408
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 49
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma	Drug: Fluocinonide Cream; Procedure: Management of Therapy Complications; Other: Questionnaire Administration	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

SECONDARY OBJECTIVES:

1. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

2. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.

3. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.

4. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.

OUTLINE:

Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive care (fluocinonide cream) Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.	Drug: Fluocinonide Cream; Given topically; Other Names: fluocinonide Lidex Vanos ; Procedure: Management of Therapy Complications; Receive fluocinonide cream; Other Names: complications of therapy, management of ; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Change in Symptom Scores of Vaginal Dryness [Baseline and 4 weeks]

   Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

2. Change in Symptom Scores of Dyspareunia [Baseline and 4 weeks]

   Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Secondary Outcome Measures

1. Change in Symptom Scores of Vaginal Itching [Baseline and 4 weeks]

   Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

2. Change in Total Vaginal Index Score. [Baseline and 4 weeks]

   Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.

3. Number of Patients Experiencing Toxicities [Over 4 weeks]

   Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.

4. Change in Vaginal Dryness Symptom Scores by Age Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

5. Change in Dyspareunia Symptom Scores by Age Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

6. Change in Vaginal Itching Symptom Scores by Age Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

7. Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

8. Change in Dyspareunia Symptom Scores by Menopause Status Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

9. Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics [Baseline and 4 weeks]

   Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

10. Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

11. Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

12. Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

13. Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

14. Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

15. Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

16. Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

17. Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

18. Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

19. Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

20. Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

21. Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients

22. Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

23. Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

24. Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics [Baseline and 4 weeks]

    Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention

• Vaginal dryness or dyspareunia must be present for at least two months prior to study entry

• Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study

• Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream

• Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance

• Subjects must sign informed consent

• Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent

Exclusion Criteria:

• Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)

• Use of any estrogen containing medications, products, or preparations

• Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted

• Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia

• Subject reported symptoms of vaginal infection with significant vaginal discharge or odor

• Known current vaginal infection

• Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms

• Known intolerance of topical steroid preparations

• Pregnant or lactating women (to be obtained via subject report only)

• Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome

• No prior chemotherapeutic treatment for any malignancy other than breast cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kathleen Kemmer, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Kemmer, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT01422408
• Other Study ID Numbers: IRB00007265; NCI-2011-01234; CPC-11028-L; 7265; P30CA69533OD
• First Posted: Aug 24, 2011
• Last Update Posted: Aug 9, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Breast Neoplasms; Fluocinonide

Study Results

Participant Flow

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Period Title: Overall Study
STARTED	34
COMPLETED	30
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Supportive Care
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 85.3%
>=65 years	5 14.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.44 (9.39)
Sex: Female, Male (Count of Participants)
Female	34 100%
Male	0 0%
Menopause status (Count of Participants)
Pre-menopausal	1 2.9%
Post-menopausal	33 97.1%
Current endocrine therapy (Count of Participants)
Anastrazole	7 20.6%
Exemestane	3 8.8%
Letrozole	13 38.2%
Tamoxifen	11 32.4%
Prior cytotoxic chemotherapy received (Count of Participants)
Prior cytotoxic chemotherapy	14 41.2%
No prior cytotoxic chemotherapy	20 58.8%
Indications for endocrine therapy (Count of Participants)
Adjuvant	33 97.1%
Prophylaxis	1 2.9%
Severe baseline symptoms, Dryness (Count of Participants)
Severe	15 44.1%
Not severe	19 55.9%
Severe baseline symptoms, Dyspareunia (Count of Participants)
Severe	15 44.1%
Not severe	10 29.4%
Missing/not reported	9 26.5%
Severe baseline symptoms, Itching (Count of Participants)
Severe	1 2.9%
Not severe	33 97.1%

Outcome Measures

1. Primary Outcome

Title	Change in Symptom Scores of Vaginal Dryness
Description	Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Median (Inter-Quartile Range) [units on a scale]	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
	Type of Statistical Test	Other
	Comments	Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	2.5% significance level to account for two co-primary endpoints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
	Type of Statistical Test	Other
	Comments	Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Since there are two-co-primary endpoints, the significance level is 2.5%
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0 to 0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Symptom Scores of Dyspareunia
Description	Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Median (Inter-Quartile Range) [units on a scale]	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
	Type of Statistical Test	Other
	Comments	Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis	p-Value	0.002
	Comments	2.5% significance level to account for two co-primary endpoints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
	Type of Statistical Test	Other
	Comments	Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
Statistical Test of Hypothesis	p-Value	0.062
	Comments	Since there are two-co-primary endpoints, the significance level is 2.5%
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Symptom Scores of Vaginal Itching
Description	Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Median (Inter-Quartile Range) [units on a scale]	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
	Type of Statistical Test	Other
	Comments	Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Change in Total Vaginal Index Score.
Description	Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Median (Inter-Quartile Range) [units on a scale]	-5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
	Type of Statistical Test	Other
	Comments	2.5% significance level to account for two co-primary endpoints.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Number of Patients Experiencing Toxicities
Description	Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
Time Frame	Over 4 weeks

Outcome Measure Data

Analysis Population Description

Toxicity and safety analyses will be conducted using the safety analysis set.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Count of Participants [Participants]	1 2.9%

6. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Age Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Age 18-45	-1.5
Age 46-55	-2.0
Age 56-65	-2.0
Age > 65	-2.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1029
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

7. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Age Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Age 18-45	-1
Age 46-55	-2
Age 56-65	-2.5
Age > 65	-3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2678
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

8. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Age Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Age 18-45	-0.5
Age 46-55	-1
Age 56-65	-1
Age > 65	-0.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2472
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

9. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Pre-Menopause	-2
Post-menopause	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.507
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

10. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Pre-Menopause	NA
Post-menopause	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3676
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

11. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Pre-Menopause	-1
Post-menopause	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6023
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

12. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Anastrazole	-2
Exemestane	-2
Letrozole	-2
Tamoxifen	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6587
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

13. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Anastrazole	-2
Exemestane	-2
Letrozole	-2.5
Tamoxifen	-1.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8772
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

14. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Anastrazole	-0.5
Exemestane	-1
Letrozole	-0.5
Tamoxifen	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7395
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

15. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Yes	-2
No	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9618
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

16. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Yes	-2
No	-2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5113
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

17. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Yes	-1
No	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8833
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

18. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Adjuvant	-2
Prophylaxis	-3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7983
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

19. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Adjuvant	-2
Prophylaxis	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4937
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

20. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
Description	Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
Adjuvant	-1
Prophylaxis	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9106
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

21. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
Description	Association of response in symptoms with patient reported compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
50 - 74%	-2
>= 75%	-2
Missing / not reported	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.507
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

22. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
Description	Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
50 - 74%	NA
>= 75%	-2
Missing / not reported	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3676
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

23. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
Description	Association of response in symptoms with patient reported compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of compliance reported by patients
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
50 - 74%	-1
>= 75%	-1
Missing / not reported	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6023
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

24. Secondary Outcome

Title	Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
Description	Association of response in symptoms with tube weight based compliance (Dryness) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
< 25%	-1
25 - 49%	-2
50 - 74%	-2
>= 75%	-2
Missing / not reported	-2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08531
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

25. Secondary Outcome

Title	Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
Description	Association of response in symptoms with tube weight based compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
< 25%	-1
25 - 49%	-2
50 - 74%	-2
>= 75%	-2
Missing / not reported	-3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2011
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

26. Secondary Outcome

Title	Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
Description	Association of response in symptoms with tube weight based compliance (Itching) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Groups are made by % of tube used by weight.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Measure Participants	34
< 25%	-1
25 - 49%	-1
50 - 74%	0
>= 75%	-1
Missing / not reported	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Fluocinonide Cream)
	Comments	In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1187
	Comments	No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
	Method	ANOVA
	Comments	Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.

Adverse Events

Time Frame	End of study week 1, 2, 3, 4
Adverse Event Reporting Description	Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Arm/Group Title	Supportive Care (Fluocinonide Cream)
Arm/Group Description	This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
All Cause Mortality
	Supportive Care (Fluocinonide Cream)
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Serious Adverse Events
	Supportive Care (Fluocinonide Cream)
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Supportive Care (Fluocinonide Cream)
	Affected / at Risk (%)	# Events
Total	24/34 (70.6%)
General disorders
Headache	1/34 (2.9%)	1
Skin and subcutaneous tissue disorders
Bullous dermatitis	1/34 (2.9%)	1
Flushing	1/34 (2.9%)	1
Pain of skin	23/34 (67.6%)	23
Pruritis	1/34 (2.9%)	1
Rash acneiform	1/34 (2.9%)	1
Vaginal discharge	2/34 (5.9%)	2
Vaginal inflammation	1/34 (2.9%)	1

Limitations/Caveats

Original plan was to use GEE modeling for secondary analysis of primary endpoints. Missing data and small counts caused us to perform this analysis using other statistical methods. Data was categorized and tested using McNemar's Test for results

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.