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

CompletedOBSERVATIONAL
Enrollment

541

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Breast CancerFatigueHypothyroidism
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

Trial Locations (41)

10466

MBCCOP - Our Lady of Mercy Comprehensive Cancer Center, The Bronx

Our Lady of Mercy Medical Center Comprehensive Cancer Center, The Bronx

27103

Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem

27534

Southeastern Medical Oncology Center - Goldsboro, Goldsboro

27893

Southeastern Medical Oncology Center - Wilson, Wilson

28043

Rutherford Internal Medicine Associates, PA, Forest City

28791

Pardee Memorial Hospital, Hendersonville

28801

Mission Hospitals - Memorial Campus, Asheville

29303

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29621

AnMed Cancer Center, Anderson

30607

Northeast Georgia Cancer Care, LLC - Medical Oncology, Athens

34788

Cancer Centers of Central Florida, PA, Leesburg

48073

William Beaumont Hospital - Royal Oak Campus, Royal Oak

48085

William Beaumont Hospital - Troy Campus, Troy

56601

MeritCare Bemidji, Bemidji

58122

CCOP - MeritCare Hospital, Fargo

Roger Maris Cancer Center at MeritCare Hospital, Fargo

62002

Saint Anthony's Hospital at Saint Anthony's Health Center, Alton

62864

Good Samaritan Regional Health Center, Mount Vernon

63141

CCOP - St. Louis-Cape Girardeau, St Louis

David C. Pratt Cancer Center at St. John's Mercy, St Louis

63701

Southeast Cancer Center, Cape Girardeau

63703

Saint Francis Medical Center, Cape Girardeau

65804

CCOP - Cancer Research for the Ozarks, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

70112

MBCCOP - LSU Health Sciences Center, New Orleans

76508

CCOP - Scott and White Hospital, Temple

Scott and White Cancer Institute, Temple

80538

McKee Medical Center, Loveland

85006-2726

CCOP - Western Regional, Arizona, Phoenix

80631-5199

North Colorado Medical Center, Greeley

33612-9497

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa

30912-3500

Medical College of Georgia Cancer Center, Augusta

30912-4000

MBCCOP - Medical College of Georgia Cancer Center, Augusta

71130-3932

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport

48073-6769

CCOP - Beaumont, Royal Oak

65804-2263

St. John's Regional Health Center, Springfield

07112

Newark Beth Israel Medical Center, Newark

27534-9479

CCOP - Southeast Cancer Control Consortium, Goldsboro

27403-1198

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro

28687-1828

Iredell Memorial Hospital, Statesville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of South Florida

OTHER

NCT00336102 - Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers | Biotech Hunter | Biotech Hunter