Women's Healthy Eating and Living Study
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.
Behavioral: educational/counseling intervention
Behavioral: therapeutic dietary intervention
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Dietary Intervention in Women Who Have Been Treated For Stage I, Stage II, or Stage III Breast Cancer: Women's Healthy Eating and Living (WHEL) Study|
- Breast Cancer Recurrence [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum, plasma, buffy coat, RBC, DNA at five time periods
|Study Start Date:||March 1995|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
high fiber, high vegetable, low-fat diet
|Behavioral: educational/counseling intervention Behavioral: therapeutic dietary intervention|
|Behavioral: therapeutic dietary intervention|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003787
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|University of California San Diego Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Permanente Medical Group (060)|
|Oakland, California, United States, 94611-5400|
|University of California Davis School of Medicine|
|Sacramento, California, United States, 95616|
|Northern California Cancer Center|
|Union City, California, United States, 94587|
|United States, Oregon|
|Center for Health Research - Portland|
|Portland, Oregon, United States, 97227-1110|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||John P. Pierce, PhD||University of California, San Diego|