Nutrition Intervention in Treating Women With Breast Cancer

Phase 3

Completed

• 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.

Study Timeline

• Study Start: 1994-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-04-28
• Study First Posted: 2004-04-29
• Study Completion: 2006-12
• Status Verified: 2010-02
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (37)

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, District of Columbia, United States

Scroll for more (27 remaining)