Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
NCT ID: NCT00336102
Last Updated: 2015-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
541 participants
OBSERVATIONAL
2006-04-30
2015-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
physiologic testing
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 assessment and management
Fatigue Symptoms Inventory (FSI) survey
management of therapy complications
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
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.
physiologic testing
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 assessment and management
Fatigue Symptoms Inventory (FSI) survey
management of therapy complications
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
Interventions
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physiologic testing
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 assessment and management
Fatigue Symptoms Inventory (FSI) survey
management of therapy complications
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.
* Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.
* The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center.
Exclusion Criteria
* 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:
20 Years
80 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Nagi B. Kumar, PhD RD FADA
Role: STUDY_CHAIR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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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
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy Campus
Troy, Michigan, United States
MeritCare Bemidji
Bemidji, Minnesota, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
The Bronx, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Rutherford Internal Medicine Associates, PA
Forest City, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center - Wilson
Wilson, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States
AnMed Cancer Center
Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Scott and White Cancer Institute
Temple, Texas, United States
Countries
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Other Identifiers
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SCUSF-0502
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 0502
Identifier Type: -
Identifier Source: org_study_id
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