Women's Healthy Eating and Living Study
18 Years
70 Years
Female
Breast Cancer
Trial Information
Women's Healthy Eating and Living Study
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.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
John P. Pierce, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Federal Government
Study ID:
CDR0000066920
NCT ID:
NCT00003787
Start Date:
March 1995
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| Permanente Medical Group (060) | Oakland, California 94611-5400 |
| University of California Davis School of Medicine | Sacramento, California 95616 |
| Northern California Cancer Center | Union City, California 94587 |
| Center for Health Research - Portland | Portland, Oregon 97227-1110 |
