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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
  Purpose

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 Intervention Phase
Breast Cancer
Behavioral: educational/counseling intervention
Behavioral: therapeutic dietary intervention
Phase 3

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Breast Cancer Recurrence [ Time Frame: Lifetime ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Lifetime ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 3000
Study Start Date: March 1995
Estimated Study Completion Date: July 2016
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
high fiber, high vegetable, low-fat diet
Behavioral: educational/counseling intervention Behavioral: therapeutic dietary intervention
Control
NCI-recommended diet
Behavioral: therapeutic dietary intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003787

Locations
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
Sponsors and Collaborators
University of California, San Diego
Susan G. Komen Breast Cancer Foundation
Investigators
Study Chair: John P. Pierce, PhD University of California, San Diego
  More Information

Additional Information:
Publications:
Parker BA, Flatt SW, Mortimer JA, et al.: Impact of hormone replacement therapy on breast cancer: Women's Healthy Eating and Living (WHEL) study experience. [Abstract] Breast Cancer Res Treat 106 (1): A-1055, S59, 2007.
Pierce JP, Natarajan L, Cann BJ, et al.: The influence of a very high vegetable-fruit-fiber, low-fat diet on prognosis following treatment for breast cancer: results from the Womens Healthy Eating and Living (WHEL) randomized trial. [Abstract] Breast Cancer Res Treat 106 (1): A-61, S16, 2007.

Responsible Party: John P. Pierce, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00003787     History of Changes
Other Study ID Numbers: UCSD-980919, CDR0000066920, UCSD-WHEL, NCI-G99-1508
Study First Received: November 1, 1999
Last Updated: May 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, San Diego:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014