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Thyroid Dysfunction in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer Who Are Planning to Undergo Chemotherapy Compared to Thyroid Dysfunction in Healthy Volunteers

This study has suspended participant recruitment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00336102
First received: June 8, 2006
Last updated: January 11, 2013
Last verified: September 2010
History of Changes
  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
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:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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
  • Compare change in thyroid function from baseline to 24 months after enrollment

Secondary Outcome Measures:
  • Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment

Estimated Enrollment: 550
Study Start Date: April 2006
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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
Criteria

DISEASE CHARACTERISTICS:

  • Patient (case)

    • Newly diagnosed stage I-IIIB primary breast cancer

      • Operable disease
    • Scheduled to receive neoadjuvant or adjuvant doxorubicin hydrochloride, cyclophosphamide, and a taxane (taxane may be given concurrently with doxorubicin hydrochloride and cyclophosphamide or following doxorubicin hydrochloride and cyclophosphamide)
    • Baseline thyroid-stimulating hormone (TSH) < 10 μ IU/mL
    • No diagnosis of hyperthyroidism or hypothyroidism by TSH level
    • 25 to 75 years of age
    • Hormone receptor status not specified

  • Age-matched healthy volunteer (control)

    • No evidence of breast cancer confirmed by mammography (women 40 years of age and older) or clinical breast exam (women under age 40) within the past 2 years
    • No prior cancer (except nonmelanoma skin cancer)
    • From the same general geographic area as the patient
    • Within 5 years of the patient's age

    • Cannot be a blood relative of the patient

      • Friends, neighbors, or women from social activities, local businesses, or doctor's offices allowed
    • Must live near or in the same town as the patient

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No other prior cancer (except non-melanoma skin cancer) (patient)
  • Not pregnant or nursing
  • Not planning to become pregnant within the next 2 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Preoperative radiotherapy allowed (patient)
  • No chemotherapy or adjuvant hormonal therapy prior to baseline sample collection (patient)

  • Not scheduled to receive neoadjuvant hormonal therapy (patient)

    • Patients who will receive adjuvant hormonal therapy are eligible
  • Not scheduled to receive trastuzumab (Herceptin®) (patient)
  • Concurrent enrollment on another research trial allowed provided the trial do not impact eligibility criteria for this protocol
  • No concurrent chemotherapeutic regimen other than doxorubicin hydrochloride, cyclophosphamide, and a taxane (patient)
  • No concurrent monoclonal antibodies or other biologic therapy (patient)
  • No concurrent treatment for hypothyroidism (patient)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336102

  Show 41 Study Locations
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
Study Chair: Nagi B. Kumar, PhD, RD, FADA H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00336102     History of Changes
Other Study ID Numbers: CDR0000458070, SCUSF-0502, MCC-0502
Study First Received: June 8, 2006
Last Updated: January 11, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 May 16, 2013