Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance - Full Text View

Purpose

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	Intervention
Prostate Cancer	Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Procedure: therapeutic dietary intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Oncology Trials:

Primary Outcome Measures:

Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression defined by PSADT and time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Time to treatment [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	464
Study Start Date:	January 2011
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive the MEAL program intervention with dietary education and telephone counseling sessions of 24 months; the "Participant Notebook", which provides written material describing the counseling program, dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and recipes and articles about diet and prostate cancer. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change and include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.	Behavioral: telephone-based intervention Patients undergo telephone counseling Other: counseling intervention Patients undergo telephone counseling Other: educational intervention Patients receive detailed or general newsletters Procedure: therapeutic dietary intervention Patients receive dietary education
Active Comparator: Arm II Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.	Other: educational intervention Patients receive detailed or general newsletters

Arms

Assigned Interventions

Experimental: Arm I

Patients receive the MEAL program intervention with dietary education and telephone counseling sessions of 24 months; the "Participant Notebook", which provides written material describing the counseling program, dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and recipes and articles about diet and prostate cancer. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change and include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.

Behavioral: telephone-based intervention

Patients undergo telephone counseling

Other: counseling intervention

Patients undergo telephone counseling

Other: educational intervention

Patients receive detailed or general newsletters

Procedure: therapeutic dietary intervention

Patients receive dietary education

Active Comparator: Arm II

Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.

Other: educational intervention

Patients receive detailed or general newsletters

Detailed Description:

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 (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
Arm II: Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies.

Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months.

After study entry, patients are followed up every 3 months for 2 years.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to presentation
- < 25% of biopsy tissue cores positive for cancer
- ≤ 50% of any one biopsy tissue core positive for cancer
Clinical stage ≤ T2a
Patients who have prostate cancer with distant metastases are not eligible
For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7
Serum PSA < 10 ng/mL
- Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
Patients are offered registration to the correlative study CALGB-151105

PATIENT CHARACTERISTICS:

Life expectancy of at least 3 years
Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone
Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible
Successful completion of three 24-hour dietary recalls during the run-in period

PRIOR CONCURRENT THERAPY:

Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy are not eligible
Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible
Patients who are currently taking coumadin are not eligible
Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as measured by the run-in dietary recalls, are not eligible
Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior to preregistration are not eligible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238172

Show 180 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:	J. Kellogg Parsons, MD, MHS	University of California, San Diego
Study Chair:	James Marshall, PhD	Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Alliance for Clinical Oncology Trials ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:	NCT01238172 History of Changes
Other Study ID Numbers:	CDR0000687958, CALGB-70807
Study First Received:	November 9, 2010
Last Updated:	April 25, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Alliance for Clinical Oncology Trials:

stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Prostatic Neoplasms
Disease Progression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013