This phase II trial studies how well exercise, motivational phone calls, and health information work in maintaining optimal health in prostate cancer survivors. Exercise and healthy diet may improve overall health in prostate cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03459755.
PRIMARY OBJECTIVES:
I. To show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor immune response which in turn may correlate with improved health-related quality of life (HRQOL) in prostate cancer (PCa) survivors.
SECONDARY OBJECTIVES:
I. Evaluate the effect of lifestyle intervention on physical activity (PA) and diet and define their relationship with AGE, AGE pre-cursor and HRQOL in men diagnosed with stage I-III PCa.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive usual care.
ARM II:
PHASE I: Participants engage in physical activity 3 days per week (2 at cardiac rehabilitation center, 1 elsewhere) over at least 150 minutes (2.5 hours) per week for 12 weeks and receive weekly motivational telephone calls and health and fitness information.
PHASE II: Participants engage in physical activity on their own at least 3 days per week and at a cardiac rehabilitation center once every 3 weeks for 12 weeks.
PHASE III: Participants engage in physical activity on their own at least 3 days per week and receive motivational phone calls every other week for 28 weeks.
After completion of study, participants are followed up at 24 and 52 weeks.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorDavid Turner