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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Fatigue, Hypothyroidism

Intervention / Treatment
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* Other: physiologic testing
* Procedure: fatigue assessment and management
* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 Breast Cancer Patient Cases<br>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<br>* 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.<br>* Other names: thyroid function tests;Procedure: fatigue assessment and management<br>* Fatigue Symptoms Inventory (FSI) survey<br>* Other names: Fatigue Symptoms Inventory;Procedure: management of therapy complications<br>* 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<br>|
| Group 2 Healthy Controls<br>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<br>* 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.<br>* Other names: thyroid function tests;Procedure: fatigue assessment and management<br>* Fatigue Symptoms Inventory (FSI) survey<br>* Other names: Fatigue Symptoms Inventory;Procedure: management of therapy complications<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, hypothyroidism, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer