Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
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|ClinicalTrials.gov Identifier: NCT01238172|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: dietary education and counseling Other: prostate cancer foundation booklet||Phase 3|
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.
- To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||464 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||April 2018|
Experimental: Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
|Other: dietary education and counseling|
Experimental: Arm B - Prostate Cancer Foundation Booklet
Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.
|Other: prostate cancer foundation booklet|
- disease progression [ Time Frame: Up to 2 years ]
- time to progression [ Time Frame: Up to 2 years ]
- time to treatment [ Time Frame: Up to 2 years ]
- quality of life [ Time Frame: Up to 2 years ]
- dietary recall evaluated at baseline, month 12 and month 24 [ Time Frame: Up to 2 years ]
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): NCT01238172
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|Study Chair:||J. Kellogg Parsons, MD, MHS||University of California, San Diego|