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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Daniel W. Nixon, MD
Study Chair
Medical University of South Carolina
United States: Federal Government
CDR0000063537
NCT00002564
April 1994
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Sharp Healthcare - Murrieta | Murrieta, California 92562 |
Permanente Medical Group (060) | Oakland, California 94611-5400 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Bennett Cancer Center | Stamford, Connecticut 06902 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
Shands Cancer Center | Gainesville, Florida 32610 |
Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Palm Beach Oncology-Hematology at the Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Midwestern Regional Medical Center | Zion, Illinois 60099 |
Women to Women | Yarmouth, Maine 04096 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
Surgical Associates | Albuquerque, New Mexico 87102 |
North Shore University Hospital | Manhasset, New York 11030 |
American Health Foundation | New York, New York 10017 |
Kaiser Permanente Center for Health Research | Portland, Oregon 97227-1098 |
Spohn Hospital South | Corpus Christi, Texas 78414 |
Texas Oncology, P.A. | Dallas, Texas 75246 |