The Men s Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
Trial status: Open for Enrollment
Why is this study being done?
- 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 (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.
Who is eligible to participate?
- 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
- 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