NCT00336102

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 541 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Fatigue
• Hypothyroidism

Interventions

Type	Name	Description
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.
PROCEDURE	fatigue assessment and management	Fatigue Symptoms Inventory (FSI) survey
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

Timeline

• Start date: 2006-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2006-06-12
• Last updated: 2015-07-09

Locations

41 sites across 1 country: United States