Diet and Exercise Interventions for Improving Outcomes in Men with Prostate Cancer
This trial studies how well diet and exercise interventions work in improving biological, clinical, and quality of life outcomes in men with prostate cancer undergoing radical prostatectomy. Following diet and exercise interventions may prevent the prostate cancer from coming back or progressing.
Inclusion Criteria
- Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment
- Able to speak and read English
- Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
- Ability to understand a written informed consent document, and the willingness to sign it
- Age >= 18 years
Exclusion Criteria
- Cannot have neoadjuvant radiation or hormone therapy planned prior to surgery at time of enrollment (if enrolling > 4 weeks prior to RP)
- Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions * Heart attack * Heart surgery, cardiac catherization, or coronary angioplasty * Pacemaker/implantable cardiac defibrillator/rhythm disturbance * Heart valve disease * Heart failure * Heart transplantation * Congenital heart disease * Diabetes * Kidney (renal) disease * Chest discomfort with exertion * Unreasonable breathlessness * Dizziness, fainting, or blackouts * Ankle swelling * Unpleasant awareness of forceful, rapid or irregular heart rate * Burning or cramping sensations in your lower legs when walking short distance
- Men already meeting both aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: 1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination; 2) 2 or more days per week of resistance exercise; 3) 8 or more resistance exercises per session
- Men meeting all 7 prostate-specific dietary recommendations
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03999151.
PRIMARY OBJECTIVE:
I. Evaluate the effect of a 2-year intervention of exercise versus (vs.) diet vs. exercise + diet vs. usual care on prostate-specific antigen (PSA) level & recurrence.
SECONDARY OBJECTIVES:
I. Determine the effect of a pre-surgical intervention of Groups A vs. B vs. C vs. D on messenger ribonucleic acid (mRNA) pathways in prostate tumors.
II. Evaluate the effect of the intervention on a validated prognostic score.
III. Compare sexual and urinary function, anxiety, depression, and overall quality of life (QOL) across groups.
IV. Compare exercise and diet behaviors across groups over time using patient reported data and accelerometer data.
V. Evaluate intervention feasibility (intervention component use) and acceptability (self report: surveys and/or interviews).
VI. Exercise and diet self-efficacy/confidence (self-report: surveys and coaching calls).
OTHER ASSESSMENTS OBJECTIVES:
I. Compare blood biomarkers across groups over time, including metabolic markers, C-reactive protein (CRP), glycosylated hemoglobin (HbA1c), and lipid panel.
II. Compare other self-reported outcomes such as sleep, barriers regarding lifestyle habits, social support, satisfaction with cancer care.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP A (REFERENCE GROUP): Patients receive educational material about the benefits of exercise and diet around the date of surgery and participate in a 9-week text messaging program focused on recovery beginning 2 weeks after surgery.
GROUP B: Patients receive educational material and participate in text messaging program as in Group A. Patients have access to an online portal consisting of resistance exercise workouts, heart rate monitors, and resistance bands. Patients also participant in 9 sessions with an exercise coach over 30-60 minutes within 2 weeks after enrollment over 2 years and receive additional interactive text messages up to 2 years to increase physical activity.
GROUP C: Patients receive educational material and participate in 9-week text messaging program as in Group A. Patients have access to an online portal containing shopping guides, online archive of recipes, and a food planner. Patients also participant in 9 sessions with a diet coach over 30-60 minutes within 2 weeks after enrollment for over 2 years and receive additional interactive text messages up to 2 years to improve dietary behaviors.
GROUP D: Patients receive educational material and participate in 9-week text messaging program as in Group A. Patients have access to an online portal consisting of resistance exercise workouts, shopping guides, online archive of recipes, and a food planner, heart rate monitor, and resistance bands. Patients also participate in 18 sessions with an exercise and/or diet coach over 30-60 minutes within 2 weeks after enrollment for over 2 years and receive additional interactive text messages up to 2 years to increase physical activity and improve dietary behaviors.
After completion of study, patients are followed up at 30 days and then annually for 3 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorStacey Kenfield
- Primary ID175513
- Secondary IDsNCI-2018-02347, 17-23151
- ClinicalTrials.gov IDNCT03999151