Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT00336102

Collaborator

National Cancer Institute (NCI) (NIH)

541

Enrollment

Locations

110

Duration (Months)

13.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Fatigue Hypothyroidism	Other: physiologic testing Procedure: fatigue assessment and management Procedure: management of therapy complications

Detailed Description

OBJECTIVES:

Primary

Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers.
Compare the magnitude of change in thyroid function in these patients from baseline to 24 months vs in cancer-free, age-matched healthy volunteers.

Secondary

Correlate variation in thyroid function with fatigue symptom scores.
Correlate variation in thyroid function with anthropometric measurements.

OUTLINE: This is a pilot, multicenter study.

Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.

PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.

Study Design

Study Type:

Observational

Actual Enrollment :

541 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Breast Cancer Patient Cases Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.	Other: physiologic testing Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp. Other Names: thyroid function tests Procedure: fatigue assessment and management Fatigue Symptoms Inventory (FSI) survey Other Names: FSI Fatigue Symptoms Inventory Procedure: management of therapy complications If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control
Group 2 Healthy Controls Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.	Other: physiologic testing Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp. Other Names: thyroid function tests Procedure: fatigue assessment and management Fatigue Symptoms Inventory (FSI) survey Other Names: FSI Fatigue Symptoms Inventory Procedure: management of therapy complications If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control

Arm

Intervention/Treatment

Group 1 Breast Cancer Patient Cases

Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.

Other: physiologic testing

Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.

Other Names:

thyroid function tests

Procedure: fatigue assessment and management

Fatigue Symptoms Inventory (FSI) survey

Other Names:

FSI

Fatigue Symptoms Inventory

Procedure: management of therapy complications

If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control

Group 2 Healthy Controls

Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.

Other: physiologic testing

Other Names:

thyroid function tests

Procedure: fatigue assessment and management

Fatigue Symptoms Inventory (FSI) survey

Other Names:

FSI

Fatigue Symptoms Inventory

Procedure: management of therapy complications

Outcome Measures

Primary Outcome Measures

Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers [2 years]
Compare change in thyroid function from baseline to 24 months after enrollment [2 years]

Secondary Outcome Measures

Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

CASE SELECTION:

CASE INCLUSION CRITERIA:
Women between the ages of 25 and 75
Diagnosed with primary and operable Stage I - IIIB breast cancer
Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)
No chemotherapy prior to baseline sample collection
No prior history of other cancers (except non-melanoma skin cancer)
Preoperative radiation therapy is permitted
No diagnosis of hypothyroidism or hyperthyroidism.
CASE EXCLUSION CRITERIA:
Stage IV breast cancer
Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant hormonal therapy may participate)
Received adjuvant hormonal therapy or chemotherapy prior to sample collection
On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.
Patients receiving monoclonal antibodies or other biologic therapy may not participate
Patients scheduled to receive Herceptin may not participate
Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)
Women with a baseline TSH of 10 or higher will not continue on study
Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)

CONTROL SELECTION:

CONTROL INCLUSION CRITERIA:
Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.
Must live near or in the town of the case
Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)
No prior history of cancer (except non-melanoma skin cancer)
Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.
The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.
Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.
The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
2	North Colorado Medical Center	Greeley	Colorado	United States	80631-5199
3	McKee Medical Center	Loveland	Colorado	United States	80538
4	Cancer Centers of Central Florida, PA	Leesburg	Florida	United States	34788
5	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida	United States	33612-9497
6	Northeast Georgia Cancer Care, LLC - Medical Oncology	Athens	Georgia	United States	30607
7	Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-3500
8	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-4000
9	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
10	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
11	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
12	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
13	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
14	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
15	William Beaumont Hospital - Troy Campus	Troy	Michigan	United States	48085
16	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
17	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63701
18	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
19	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
20	St. John's Regional Health Center	Springfield	Missouri	United States	65804-2263
21	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65804
22	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
23	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri	United States	63141
24	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
25	MBCCOP - Our Lady of Mercy Comprehensive Cancer Center	Bronx	New York	United States	10466
26	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
27	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
28	Rutherford Internal Medicine Associates, PA	Forest City	North Carolina	United States	28043
29	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
30	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina	United States	27534
31	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina	United States	27403-1198
32	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
33	Iredell Memorial Hospital	Statesville	North Carolina	United States	28687-1828
34	Southeastern Medical Oncology Center - Wilson	Wilson	North Carolina	United States	27893
35	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
36	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
37	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota	United States	58122
38	AnMed Cancer Center	Anderson	South Carolina	United States	29621
39	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
40	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
41	Scott and White Cancer Institute	Temple	Texas	United States	76508