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

July 7, 2015 updated by: University of South Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

541

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
    • Colorado
      • Greeley, Colorado, United States, 80631-5199
        • North Colorado Medical Center
      • Loveland, Colorado, United States, 80538
        • McKee Medical Center
    • Florida
      • Leesburg, Florida, United States, 34788
        • Cancer Centers of Central Florida, PA
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC - Medical Oncology
      • Augusta, Georgia, United States, 30912-3500
        • Medical College of Georgia Cancer Center
      • Augusta, Georgia, United States, 30912-4000
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy Campus
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Bemidji
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63701
        • Southeast Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • Springfield, Missouri, United States, 65804
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804-2263
        • St. John's Regional Health Center
      • St. Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
      • Bronx, New York, United States, 10466
        • MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals - Memorial Campus
      • Forest City, North Carolina, United States, 28043
        • Rutherford Internal Medicine Associates, PA
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Greensboro, North Carolina, United States, 27403-1198
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • Statesville, North Carolina, United States, 28687-1828
        • Iredell Memorial Hospital
      • Wilson, North Carolina, United States, 27893
        • Southeastern Medical Oncology Center - Wilson
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center at Forsyth Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Texas
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
      • Temple, Texas, United States, 76508
        • Scott and White Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years
Compare change in thyroid function from baseline to 24 months after enrollment
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Nagi B. Kumar, PhD RD FADA, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCUSF 0502
  • 5U10CA081920-11 (U.S. NIH Grant/Contract)
  • SCUSF-0502 (Other Identifier: SunCoast CCOP Research Base)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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