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
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.
Observational
Observational Model: Case Control, Time Perspective: Prospective
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
No
Nagi B. Kumar, PhD RD FADA
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Data and Safety Monitoring Board
SCUSF 0502
NCT00336102
April 2006
Name | Location |
---|---|
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
William Beaumont Hospital - Troy Campus | Troy, Michigan 48085 |
Southeastern Medical Oncology Center - Goldsboro | Goldsboro, North Carolina 27534 |
Southeast Cancer Center | Cape Girardeau, Missouri 63703 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
Northeast Georgia Cancer Care, LLC - Medical Oncology | Athens, Georgia 30607 |
Scott and White Cancer Institute | Temple, Texas 76508 |
Cancer Centers of Central Florida, PA | Leesburg, Florida 34788 |
Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3500 |
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center | Bronx, New York 10466 |
Rutherford Internal Medicine Associates, PA | Forest City, North Carolina 28043 |
Southeastern Medical Oncology Center - Wilson | Wilson, North Carolina 27893 |