Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00336102
First received: June 8, 2006
Last updated: May 20, 2013
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Fatigue Hypothyroidism |
Other: physiologic testing Procedure: fatigue assessment and management Procedure: management of therapy complications |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Thyroid
U.S. FDA Resources
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Compare change in thyroid function from baseline to 24 months after enrollment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
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.
| Estimated Enrollment: | 550 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
Other: 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.
Other Name: thyroid function tests
Procedure: fatigue assessment and management
Fatigue Symptoms Inventory (FSI) survey
Other Names:
Procedure: 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. |
Other: 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.
Other Name: thyroid function tests
Procedure: fatigue assessment and management
Fatigue Symptoms Inventory (FSI) survey
Other Names:
Procedure: 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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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).
Criteria
CASE SELECTION:
- CASE INCLUSION CRITERIA:
- 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.
- CASE EXCLUSION CRITERIA:
- 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:
- CONTROL INCLUSION CRITERIA:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336102
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, Colorado | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631-5199 | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80538 | |
| United States, Florida | |
| Cancer Centers of Central Florida, PA | |
| Leesburg, Florida, United States, 34788 | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Northeast Georgia Cancer Care, LLC - Medical Oncology | |
| Athens, Georgia, United States, 30607 | |
| MBCCOP - Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3500 | |
| United States, Illinois | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| Good Samaritan Regional Health Center | |
| Mount Vernon, Illinois, United States, 62864 | |
| United States, Louisiana | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Michigan | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| William Beaumont Hospital - Troy Campus | |
| Troy, Michigan, United States, 48085 | |
| United States, Minnesota | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| United States, Missouri | |
| Saint Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63703 | |
| Southeast Cancer Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65804 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804-2263 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| MBCCOP - Our Lady of Mercy Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Rutherford Internal Medicine Associates, PA | |
| Forest City, North Carolina, United States, 28043 | |
| Southeastern Medical Oncology Center - Goldsboro | |
| Goldsboro, North Carolina, United States, 27534 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | |
| Greensboro, North Carolina, United States, 27403-1198 | |
| Pardee Memorial Hospital | |
| Hendersonville, North Carolina, United States, 28791 | |
| Iredell Memorial Hospital | |
| Statesville, North Carolina, United States, 28687-1828 | |
| Southeastern Medical Oncology Center - Wilson | |
| Wilson, North Carolina, United States, 27893 | |
| Forsyth Regional Cancer Center at Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Roger Maris Cancer Center at MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Scott and White Cancer Institute | |
| Temple, Texas, United States, 76508 | |
Sponsors and Collaborators
University of South Florida
Investigators
| Study Chair: | Nagi B. Kumar, PhD RD FADA | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00336102 History of Changes |
| Other Study ID Numbers: | SCUSF 0502, SCUSF-0502, 5U10CA081920-11 |
| Study First Received: | June 8, 2006 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
fatigue hypothyroidism stage I breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Hypothyroidism Thyroid Diseases Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013