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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Other: dietary education and counseling
Other: prostate cancer foundation booklet
Enrollment 478
Recruitment Details  
Pre-assignment Details Of 602 total patients were pre-registered, only 478 patients were deemed eligible and randomized.
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description Patients will receive dietary education and telephone counseling sessions over 24 months. Patients receive education material about diet, nutrition, exercise and cancer.
Period Title: Overall Study
Started [1] 237 241
Completed [2] 226 217
Not Completed 11 24
Reason Not Completed
Ineligible: based on Eligibility Review             2             5
Ineligible: based on Central Path Review             9             19
[1]
Intention-to-treat (ITT) Cohort
[2]
modified intention-to-treat (m-ITT) Cohort
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet Total
Hide Arm/Group Description Patients will receive dietary education and telephone counseling sessions over 24 months. Patients receive education material about diet, nutrition, exercise and cancer. Total of all reporting groups
Overall Number of Baseline Participants 226 217 443
Hide Baseline Analysis Population Description
The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 217 participants 443 participants
63.7  (6.5) 63.5  (6.6) 63.6  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 217 participants 443 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
226
 100.0%
217
 100.0%
443
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 217 participants 443 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
1
   0.2%
Asian
6
   2.7%
9
   4.1%
15
   3.4%
Black or African American
24
  10.6%
26
  12.0%
50
  11.3%
Hispanic or Latino
9
   4.0%
7
   3.2%
16
   3.6%
More than one race
0
   0.0%
2
   0.9%
2
   0.5%
Native Hawaiian or Pacific Islander
0
   0.0%
1
   0.5%
1
   0.2%
White
186
  82.3%
171
  78.8%
357
  80.6%
Not Reported
0
   0.0%
1
   0.5%
1
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 226 participants 217 participants 443 participants
226
 100.0%
217
 100.0%
443
 100.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 226 participants 217 participants 443 participants
28.7  (5.9) 28.3  (3.7) 28.5  (4.9)
1.Primary Outcome
Title Time to Progression
Hide Description 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 Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was based on the modified intention-to-treat (m-ITT) analysis population. The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description:
Patients will receive dietary education and telephone counseling sessions over 24 months.
Patients receive education material about diet, nutrition, exercise and cancer.
Overall Number of Participants Analyzed 226 217
Median (95% Confidence Interval)
Unit of Measure: days
683.0
(471.0 to 733.0)
549.0
(418.0 to 728.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.75 to 1.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed
Hide Description 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.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description:
Patients will receive dietary education and telephone counseling sessions over 24 months.
Patients receive education material about diet, nutrition, exercise and cancer.
Overall Number of Participants Analyzed 226 217
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.3%
2
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
0.23 to 8.41
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description 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
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description:
Patients will receive dietary education and telephone counseling sessions over 24 months.
Patients receive education material about diet, nutrition, exercise and cancer.
Overall Number of Participants Analyzed 150 140
Median (Full Range)
Unit of Measure: score on a scale
2.0
(-39.5 to 41.9)
2.8
(-42.3 to 34.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.995
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall
Hide Description 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.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data on the individual study measure at baseline and 24 months were included in the analysis
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description:
Patients will receive dietary education and telephone counseling sessions over 24 months.
Patients receive education material about diet, nutrition, exercise and cancer.
Overall Number of Participants Analyzed 233 240
Mean (95% Confidence Interval)
Unit of Measure: servings per day
2.01
(1.75 to 2.28)
0.37
(0.11 to 0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Two-sided
Time Frame Adverse events were not collected for this study.
Adverse Event Reporting Description Adverse events were not collected for this study.
 
Arm/Group Title Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Hide Arm/Group Description Patients will receive dietary education and telephone counseling sessions over 24 months. Patients receive education material about diet, nutrition, exercise and cancer.
All-Cause Mortality
Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A - MEAL Program Intervention Arm B - Prostate Cancer Foundation Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. Kellogg Parsons, M.D., MHS
Organization: Moores Cancer Center
Phone: 858-822-7874
EMail: jkparsons@ucsd.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01238172     History of Changes
Other Study ID Numbers: CALGB-70807
CALGB-70807
CDR0000687958 ( Registry Identifier: NCI Physician Data Query )
First Submitted: November 9, 2010
First Posted: November 10, 2010
Results First Submitted: February 20, 2019
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019