Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00336102
First received: June 8, 2006
Last updated: June 25, 2014
Last verified: June 2014
  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:


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:
  • FSI
  • Fatigue Symptoms Inventory
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:
  • FSI
  • Fatigue Symptoms Inventory
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336102

  Hide Study Locations
Locations
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: June 25, 2014
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 July 09, 2014