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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
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.
Age
20 - 80 years
Sex
FEMALE
Healthy Volunteers
Yes
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
Start Date
April 1, 2006
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
July 9, 2015
541
ACTUAL participants
physiologic testing
OTHER
fatigue assessment and management
PROCEDURE
management of therapy complications
PROCEDURE
Lead Sponsor
University of South Florida
Collaborators
NCT05372640
NCT05245812
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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