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.
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 Type
OBSERVATIONAL
Enrollment
541
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
Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers
Time frame: 2 years
Compare change in thyroid function from baseline to 24 months after enrollment
Time frame: 2 years
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
North Colorado Medical Center
Greeley, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Cancer Centers of Central Florida, PA
Leesburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, United States
Medical College of Georgia Cancer Center
Augusta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
...and 31 more locations