Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
- Conditions
- FatigueHypothyroidismBreast Cancer
- Interventions
- Other: physiologic testingProcedure: fatigue assessment and managementProcedure: management of therapy complications
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 541
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Breast Cancer Patient Cases physiologic testing Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Group 2 Healthy Controls fatigue assessment and management Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Group 1 Breast Cancer Patient Cases fatigue assessment and management Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Group 1 Breast Cancer Patient Cases management of therapy complications Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Group 2 Healthy Controls physiologic testing Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Group 2 Healthy Controls management of therapy complications Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.
- 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)
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center - Wilson
🇺🇸Wilson, North Carolina, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Cancer Centers of Central Florida, PA
🇺🇸Leesburg, Florida, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
Southeast Cancer Center
🇺🇸Cape Girardeau, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
🇺🇸Athens, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Southeastern Medical Oncology Center - Goldsboro
🇺🇸Goldsboro, North Carolina, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
William Beaumont Hospital - Troy Campus
🇺🇸Troy, Michigan, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Rutherford Internal Medicine Associates, PA
🇺🇸Forest City, North Carolina, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
🇺🇸Greensboro, North Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Scott and White Cancer Institute
🇺🇸Temple, Texas, United States
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States