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

Completed

• Conditions: Fatigue; Hypothyroidism; Breast Cancer

• Registration Number: NCT00336102
• Lead Sponsor: University of South Florida

Brief 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 541

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment	2 years

Trial Locations

Locations (41)

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

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