Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
Condition: Breast Cancer; Fatigue; Hypothyroidism
MeSH terms: Breast Neoplasms; Hypothyroidism; Fatigue
Study type: Observational

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.
    

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.
    

Intervention name(s): physiologic testing; fatigue assessment and management; management of therapy complications
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): 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.; Fatigue Symptoms Inventory (FSI) survey; 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
Other intervention name(s): thyroid function tests; FSI; Fatigue Symptoms Inventory
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy
        volunteers (controls). 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. Participants will be asked to nominate 2
        women to serve as their healthy control. In the event the first woman is not eligible or
        decides not to participate, the second woman will be evaluated. Controls will be women from
        the same general demographic area, have no prior history of cancer and be within 5 years of
        the patient's age (+/- 5 years).
      
Biospecimen description: 
      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.
    
Keywords: fatigue; hypothyroidism; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer