Nutrition Intervention in Treating Women With Breast Cancer
NCT ID: NCT00002564
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2500 participants
INTERVENTIONAL
1994-04-30
2006-12-31
Brief Summary
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PURPOSE: 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.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, nodal status, ER status, and type of adjuvant chemotherapy. The first group receives intensive dietary intervention for reduction of total fat intake to 15% of calories, with repeated individual and group counseling sessions. The second group receives USDA/DHHS dietary guidelines and minimal intervention. All patients who are estrogen receptor positive receive concurrent therapy with tamoxifen; cyclophosphamide, methotrexate, fluorouracil (CMF) followed by tamoxifen; doxorubicin, cyclophosphamide (AC) followed by tamoxifen; fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF) followed by tamoxifen; or AC, paclitaxel followed by tamoxifen. Patients are followed annually throughout the study.
PROJECTED ACCRUAL: Approximately 2,500 women will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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educational intervention
therapeutic dietary intervention
Eligibility Criteria
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Inclusion Criteria
48 Years
78 Years
FEMALE
No
Sponsors
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Institute for Cancer Prevention (IFCP)
OTHER
Principal Investigators
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Daniel W. Nixon, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Sharp Healthcare - Murrieta
Murrieta, California, United States
Permanente Medical Group (060)
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Bennett Cancer Center
Stamford, Connecticut, United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
Shands Cancer Center
Gainesville, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Palm Beach Oncology-Hematology at the Good Samaritan Medical Center
West Palm Beach, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Women to Women
Yarmouth, Maine, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Surgical Associates
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
American Health Foundation
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Spohn Hospital South
Corpus Christi, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin MP, Thomson CA, Grosvenor MB, Copeland T, Falk E, Day K, Blackburn GL. Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. J Am Diet Assoc. 2009 Apr;109(4):688-96. doi: 10.1016/j.jada.2008.12.016.
Chlebowski RT, Blackburn GL, Thomson CA, Nixon DW, Shapiro A, Hoy MK, Goodman MT, Giuliano AE, Karanja N, McAndrew P, Hudis C, Butler J, Merkel D, Kristal A, Caan B, Michaelson R, Vinciguerra V, Del Prete S, Winkler M, Hall R, Simon M, Winters BL, Elashoff RM. Dietary fat reduction and breast cancer outcome: interim efficacy results from the Women's Intervention Nutrition Study. J Natl Cancer Inst. 2006 Dec 20;98(24):1767-76. doi: 10.1093/jnci/djj494.
Chlebowski RT, Blackburn GL, Elashoff RE, et al.: Dietary fat reduction in postmenopausal women with primary breast cancer: phase III Women's Intervention Nutrition Study (WINS). [Abstract] J Clin Oncol 23 (Suppl 16): A-10, 3s, 2005.
Other Identifiers
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AHF-WINS
Identifier Type: -
Identifier Source: secondary_id
MRMC-CTCA-9604
Identifier Type: -
Identifier Source: secondary_id
WINS-1
Identifier Type: -
Identifier Source: secondary_id
NCI-H94-0001
Identifier Type: -
Identifier Source: secondary_id
CDR0000063537
Identifier Type: -
Identifier Source: org_study_id