Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02819921
• Collaborator: Seoul National University Bundang Hospital (Other), Korea Cancer Center Hospital (Other), Pfizer (Industry)
• Enrollment: 59
• Locations: 3
• Arms: 3
• Actual Duration (Months): 19.1
• Patients Per Site: 19.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes; Breast Neoplasms	Drug: Desvenlafaxine succinate 100mg; Drug: Desvenlafaxine succinate 50mg; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
• Actual Study Start Date: Nov 10, 2017
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Jun 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desvenlafaxine succinate 100mg Titration with 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 2 tablets of 50mg Desvenlafaxine succinate tablet once daily for 3 weeks, then taper with 50 mg Desvenlafaxine succinate tablet once daily for 3 days.	Drug: Desvenlafaxine succinate 100mg; Pristiq 100mg
Experimental: Desvenlafaxine succinate 50mg 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 1 tablets of 50mg Desvenlafaxine succinate tablet and 1 tablet of 50mg placebo tablet once daily for 3 weeks, then 50mg placebo tablet once daily for 3 days.	Drug: Desvenlafaxine succinate 50mg; Pristiq 50mg
Placebo Comparator: Placebo 50 mg placebo tablet once daily for 1 week, then 2 tablets of 50mg placebo tablet once daily for 3 weeks, then 50 mg placebo tablet once daily for 3 days.	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Reduction rate of hot flashes symptom score [From baseline to Week 5 (Intervention is started from Week 1)]

   Participants would complete self -report daily diary on which they record the number and severities (1 - 4 points) of hot flashes from baseline to week 5. Each symptom severities are multiplied by the numbers of symptoms to determine the daily hot flashes symptom score. The mean of daily hot flashes symptom score of one week is calculated and regared as a hot flashes symptom score for the week. The efficacy of Desvenlafaxine is assessed by comparing the reduction rate of weekly hot flashes symptom score (= hot flashes symptom score at week 5 - hot flashes symptom score at baseline / hot flashes symptom score of baseline) for each group.

Secondary Outcome Measures

1. Clinical impression state and change [Week 1, Week 2, Week 5]

   Clinical global impression (CGI) would be used to assess clinical impression state and change.

2. Peripheral neuropathy [Week 1, Week 2, Week 5]

   European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy(EORTC-QLQ-CIPN-20) would be used to assess peripheral neuropathy.

3. Depression [Baseline, Week 2, Week 5]

   Patient health questionnaire (PHQ-9) would be used to assess mood status.

4. Anxiety [Baseline, Week 2, Week 5]

   Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.

5. Manic or Hypomanic symptoms. [Baseline, Week 2, Week 5]

   Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.

6. Sleep quality [Baseline, Week 2, Week 5]

   Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.

7. Chonotype [Baseline]

   Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.

8. Circadian misalignment [Baseline, Week 2, Week 5]

   Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.

9. Fatigue [Baseline, Week 2, Week 5]

   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.

10. Quality of life [Baseline, Week 2, Week 5]

    Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.

11. Beliefs about medicines [Baseline]

    Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.

12. Illness perception [Baseline]

    Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.

13. Social support [Baseline]

    Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.

14. Body image [Baseline]

    Body Image Scale (BIS) would be used to assess body image.

15. Resilience [Baseline]

    Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.

16. Hormonal level [Week 2]

    Serum estradiol, follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.

17. Genetic polymorphism [Week 2]

    estrogen receptors (ESR1 PvuII; rs#2234693 and XbaI; rs#9340799 and ESR2-02; rs#4986938) and serotonin transporter gene (SLC6A4; rs#11080121) would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.

2. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.

3. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.

Exclusion Criteria:

1. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression.

2. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang	Gyeonggi-do	Korea, Republic of	10408
2	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	13620
3	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital
• Seoul National University Bundang Hospital
• Korea Cancer Center Hospital
• Pfizer

Investigators

• Principal Investigator: Bong-Jin Hahm, M.D., Ph.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02819921
• Other Study ID Numbers: WI209149
• First Posted: Jun 30, 2016
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Seoul National University Hospital: Hot Flashes; Breast Neoplasms; Tamoxifen; Desvenlafaxine Succinate
• Additional relevant MeSH terms: Breast Neoplasms; Hot Flashes; Desvenlafaxine Succinate

Study Results

No Results Posted as of Sep 20, 2019