NCT01238172

Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	dietary education and counseling
OTHER	prostate cancer foundation booklet

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-11-18
• Completion: 2019-01-15
• First posted: 2010-11-10
• Last updated: 2023-03-21
• Results posted: 2019-03-12

Locations

180 sites across 1 country: United States