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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Women's Intervention Nutrition Study (WINS): Randomized Study to Determine the Efficacy of Dietary Fat Reduction in Addition to Conventional Systemic Adjuvant Therapy in Postmenopausal Women Surgically Treated for Primary Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	48 to 78	Other	AHF-WINS MRMC-CTCA-9604, WINS-1, NCI-H94-0001, NCT00002564

Trial Description

Purpose:

Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer.

Randomized clinical trial to study the effectiveness of a low fat diet in treating postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been completely removed by surgery.

Eligibility:

• 48-78 years old
• Patients must be receiving tamoxifen
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. During individual and group counseling sessions, patients in group one will receive detailed instructions for following a low fat diet. Patients in group two will receive dietary guidelines with minimal counseling. All patients will receive follow-up evaluations once a year during the study.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Institute for Cancer Prevention

Daniel Nixon, MD, Protocol chair		Ph: 843-792-5336; 800-424-3828 Email: nixond@musc.edu

Registry Information
Official Title		A CLINICAL TRIAL TO DETERMINE THE EFFICACY OF A DIETARY FAT REDUCTION PROGRAM PROVIDED IN ADDITION TO SYSTEMIC ADJUVANT THERAPY IN THE MANAGEMENT OF PATIENTS WITH PRIMARY INVASIVE BREAST CANCER
Trial Start Date		1994-04-01
Registered in ClinicalTrials.gov		NCT00002564
Date Submitted to PDQ		1994-04-01
Information Last Verified		2007-10-15
NCI Grant/Contract Number		CA17613, CA45504

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