Women's Healthy Eating and Living Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
John P. Pierce, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00003787
First received: November 1, 1999
Last updated: May 20, 2014
Last verified: May 2014

November 1, 1999
May 20, 2014
March 1995
March 2007   (final data collection date for primary outcome measure)
Breast Cancer Recurrence [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003787 on ClinicalTrials.gov Archive Site
Mortality [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Women's Healthy Eating and Living Study
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma, buffy coat, RBC, DNA at five time periods

Non-Probability Sample

Women who were diagnosed with early-stage breast cancer within the previous 4 years, and are between the ages of 18-74

Breast Cancer
  • Behavioral: educational/counseling intervention
  • Behavioral: therapeutic dietary intervention
  • Intervention
    high fiber, high vegetable, low-fat diet
    Interventions:
    • Behavioral: educational/counseling intervention
    • Behavioral: therapeutic dietary intervention
  • Control
    NCI-recommended diet
    Intervention: Behavioral: therapeutic dietary intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
July 2016
March 2007   (final data collection date for primary outcome measure)

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

Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003787
UCSD-980919, CDR0000066920, UCSD-WHEL, NCI-G99-1508
Yes
John P. Pierce, University of California, San Diego
University of California, San Diego
  • National Cancer Institute (NCI)
  • Susan G. Komen Breast Cancer Foundation
Study Chair: John P. Pierce, PhD University of California, San Diego
University of California, San Diego
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP