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The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life. OBJECTIVES: Primary * To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients. Secondary * To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention. * To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention. * To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention. OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs \> 70 years), race (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs \> 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.
Age
50 - 80 years
Sex
MALE
Healthy Volunteers
No
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Kaiser Permanente Medical Center - Bellflower
Bellflower, California, United States
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Start Date
January 1, 2011
Primary Completion Date
November 18, 2017
Completion Date
January 15, 2019
Last Updated
March 21, 2023
478
ACTUAL participants
dietary education and counseling
OTHER
prostate cancer foundation booklet
OTHER
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494