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

NCT00336102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 541

Last updated 2015-07-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

PROCEDURE

fatigue assessment and management

Fatigue Symptoms Inventory (FSI) survey

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of South Florida

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336102 on ClinicalTrials.gov