Nutrition Intervention in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002564
- Lead Sponsor
- Institute for Cancer Prevention (IFCP)
- Brief Summary
RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer.
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
OBJECTIVES: I. Determine whether dietary fat reduction will effectively prolong disease-free and overall survival in women surgically treated for early stage breast cancer who are receiving adjuvant therapy with or without either tamoxifen, cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF), or AC followed by paclitaxel. II. Evaluate whether differences in the lipid profile are associated with dietary group assignment and dietary fat.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Palm Beach Oncology-Hematology at the Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Women to Women
🇺🇸Yarmouth, Maine, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Sharp Healthcare - Murrieta
🇺🇸Murrieta, California, United States
Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Lombardi Cancer Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Permanente Medical Group (060)
🇺🇸Oakland, California, United States
Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
American Health Foundation
🇺🇸New York, New York, United States
Surgical Associates
🇺🇸Albuquerque, New Mexico, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Kaiser Permanente Center for Health Research
🇺🇸Portland, Oregon, United States
Spohn Hospital South
🇺🇸Corpus Christi, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States