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.

Condition	Treatment or Intervention	Phase
Breast Neoplasms	Behavior: Low-fat, high in fruit, vegetables, and fiber diet	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Primary operable stage I (tumors at least 1 cm), stage II, and stage IIIA invasive breast carcinoma
• Treatment within the past 4 years by total mastectomy and axillary dissection, or breast sparing surgical removal of cancer with clear macroscopic margins and axillary dissection followed by adjuvant breast radiation
• No evidence of recurrent disease or new breast cancer since completion of initial local treatment confirmed within the past 6 months by physician evaluation, except stage I mastectomy, for which physician evaluation can be within 1 year prior to randomization
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No concurrent chemotherapy
• Endocrine therapy: No concurrent estrogen replacement therapy, including vaginal estrogen creams
• Radiotherapy: See Disease Characteristics
• Surgery: See Disease Characteristics
• Other: No concurrent enrollment in another clinical trial that has dietary restrictions or endpoints similar to this study

--Patient Characteristics--

• Age: 18 to 70 at time of diagnosis
• Sex: Female
• Menopausal status: Not specified
• Performance status: Not specified
• Life expectancy: At least 10 years (excluding breast cancer)
• Hematopoietic: Not specified
• Hepatic: No cirrhosis
• Renal: Not specified
• Other: Not pregnant; Accessible geographically and by telephone; Able to communicate dietary data via 24-hour food recall Able to commit to the intervention schedule; No comorbidity requiring a specific diet or taking a medication which contraindicates consuming a high fiber diet (e.g., systemic scleroderma, other digestive malabsorption syndromes, and insulin dependent diabetes); No other primary or recurrent invasive cancer within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
California
      Northern California Cancer Center, Union City,  California,  94587,  United States
      Permanente Medical Group (060), Oakland,  California,  94611-5400,  United States
      University of California Davis School of Medicine, Sacramento,  California,  95616,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
Oregon
      Center for Health Research - Portland, Portland,  Oregon,  97227-1110,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

John P. Pierce,  Study Chair,  University of California San Diego Cancer Center   

Study ID Numbers:  CDR0000066920; UCSD-980919; NCI-G99-1508; UCSD-WHEL
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003787
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08