Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
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|ClinicalTrials.gov Identifier: NCT01238172|
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
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)|
|Actual Enrollment :||478 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|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 18, 2017|
|Actual Study Completion Date :||January 15, 2019|
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
- Time to Progression [ Time Frame: Up to 2 years ]Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).
- Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed [ Time Frame: Up to 2 years ]Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.
- Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 [ Time Frame: Up to 2 years ]Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer [MAX-PC] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL
- Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall [ Time Frame: Up to 2 years ]At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.
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|