Women's Healthy Eating and Living Study

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: educational/counseling intervention; Behavioral: therapeutic dietary intervention

• Registration Number: NCT00003787
• Lead Sponsor: University of California, San Diego

Brief Summary

RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence.

PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.

Detailed Description

OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat is associated with a longer breast cancer event-free interval in breast cancer survivors. II. Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables, fruit, and fiber and low in fat. III. Demonstrate that the intervention can produce significant changes in circulating carotenoid and estrogen biomarkers compared to a healthy control diet. IV. Test whether the probability of a secondary cancer event is associated with change in self-reported dietary intake, circulating carotenoid concentrations, and circulating estrogen concentrations.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary regimens: Arm I: Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a randomly selected 50% sample participate in recall at 6 months. Patients are followed by telephone every 6 months for an average of 6 years.

PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.

Study Timeline

• Study Start: 1995-03
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-06-02
• Study First Posted: 2004-06-03
• Primary Completion: 2007-03
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3088

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	therapeutic dietary intervention	high fiber, high vegetable, low-fat diet
Control	therapeutic dietary intervention	NCI-recommended diet
Intervention	educational/counseling intervention	high fiber, high vegetable, low-fat diet

Primary Outcome Measures

Name	Time	Method
Breast Cancer Recurrence	Lifetime

Secondary Outcome Measures

Name	Time	Method
Mortality	Lifetime

Trial Locations

Locations (7)

Northern California Cancer Center; 🇺🇸 Union City, California, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

University of California Davis School of Medicine; 🇺🇸 Sacramento, California, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Permanente Medical Group (060); 🇺🇸 Oakland, California, United States

Center for Health Research - Portland; 🇺🇸 Portland, Oregon, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States