Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
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
3 other identifiers
observational
541
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 8, 2006
CompletedFirst Posted
Study publicly available on registry
June 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 9, 2015
July 1, 2015
9.2 years
June 8, 2006
July 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment
2 years
Study Arms (2)
Group 1 Breast Cancer Patient Cases
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
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.
Interventions
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
Eligibility Criteria
This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy volunteers (controls). 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. Participants will be asked to nominate 2 women to serve as their healthy control. In the event the first woman is not eligible or decides not to participate, the second woman will be evaluated. Controls will be women from the same general demographic area, have no prior history of cancer and be within 5 years of the patient's age (+/- 5 years).
You may qualify if:
- Women between the ages of 25 and 75
- Diagnosed with primary and operable Stage I - IIIB breast cancer
- Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)
- No chemotherapy prior to baseline sample collection
- No prior history of other cancers (except non-melanoma skin cancer)
- Preoperative radiation therapy is permitted
- No diagnosis of hypothyroidism or hyperthyroidism.
You may not qualify if:
- Stage IV breast cancer
- Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant hormonal therapy may participate)
- Received adjuvant hormonal therapy or chemotherapy prior to sample collection
- On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.
- Patients receiving monoclonal antibodies or other biologic therapy may not participate
- Patients scheduled to receive Herceptin may not participate
- Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)
- Women with a baseline TSH of 10 or higher will not continue on study
- Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)
- CONTROL SELECTION:
- Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.
- Must live near or in the town of the case
- Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)
- No prior history of cancer (except non-melanoma skin cancer)
- Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (41)
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726, United States
North Colorado Medical Center
Greeley, Colorado, 80631-5199, United States
McKee Medical Center
Loveland, Colorado, 80538, United States
Cancer Centers of Central Florida, PA
Leesburg, Florida, 34788, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, 30607, United States
Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-3500, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy Campus
Troy, Michigan, 48085, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
St. John's Regional Health Center
Springfield, Missouri, 65804-2263, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
Rutherford Internal Medicine Associates, PA
Forest City, North Carolina, 28043, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, 27403-1198, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28687-1828, United States
Southeastern Medical Oncology Center - Wilson
Wilson, North Carolina, 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, 58122, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Scott and White Cancer Institute
Temple, Texas, 76508, United States
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nagi B. Kumar, PhD RD FADA
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2006
First Posted
June 12, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 9, 2015
Record last verified: 2015-07