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 - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00336102

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 Cancer-Related Problem/Condition Fatigue	Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: physiologic testing

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Thyroid

U.S. FDA Resources

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

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:	440
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2010 (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 440 patients and health 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 doxorubicin hydrochloride, cyclophosphamide, and a taxane
- 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 or clinical breast exam 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

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
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
No concurrent chemotherapeutic regimen other than doxorubicin hydrochloride, cyclophosphamide, and a taxane (patient)
No concurrent treatment for hypothyroidism (patient)

Contacts and Locations

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

Show 36 Study Locations

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Nagi B. Kumar, PhD, RD, FADA

H. Lee Moffitt Cancer Center and Research Institute

More Information

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

Study ID Numbers:	CDR0000458070, MCC-0502
Study First Received:	June 8, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00336102
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Signs and Symptoms
Fatigue
Skin Diseases
Endocrine System Diseases
Hypothyroidism

Breast Neoplasms
Endocrinopathy
Healthy
Breast Diseases
Thyroid Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009