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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336102
• Other study ID #: SCUSF 0502
• Secondary ID: SCUSF-05025U10CA
• Status: Completed
• Phase: N/A
• First received: June 8, 2006
• Last updated: July 7, 2015
• Start date: April 2006
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Hypothyroidism

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	AnMed Cancer Center	Anderson	South Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Northeast Georgia Cancer Care, LLC - Medical Oncology	Athens	Georgia
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Medical College of Georgia Cancer Center	Augusta	Georgia
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	MBCCOP - Our Lady of Mercy Comprehensive Cancer Center	Bronx	New York
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Southeast Cancer Center	Cape Girardeau	Missouri
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota
United States	Rutherford Internal Medicine Associates, PA	Forest City	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina
United States	North Colorado Medical Center	Greeley	Colorado
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Cancer Centers of Central Florida, PA	Leesburg	Florida
United States	McKee Medical Center	Loveland	Colorado
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Scott and White Cancer Institute	Temple	Texas
United States	William Beaumont Hospital - Troy Campus	Troy	Michigan
United States	Southeastern Medical Oncology Center - Wilson	Wilson	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers		2 years	No
Primary	Compare change in thyroid function from baseline to 24 months after enrollment		2 years	No
Secondary	Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment		2 years	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database