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Women's Healthy Eating and Living Study

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ClinicalTrials.gov Identifier: NCT00003787
Recruitment Status : Active, not recruiting
First Posted : June 3, 2004
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Behavioral: educational/counseling intervention 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.

Study Design

Study Type : Observational
Estimated Enrollment : 3000 participants
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
Study Start Date : March 1995
Primary Completion Date : March 2007
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
high fiber, high vegetable, low-fat diet
Behavioral: educational/counseling intervention Behavioral: therapeutic dietary intervention
NCI-recommended diet
Behavioral: therapeutic dietary intervention

Outcome Measures

Primary Outcome Measures :
  1. Breast Cancer Recurrence [ Time Frame: Lifetime ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Lifetime ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, buffy coat, RBC, DNA at five time periods

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
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
More Information

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 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 3, 2004    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by John P. Pierce, 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
Neoplasms by Site
Breast Diseases
Skin Diseases