Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial

摘要: A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men prostate cancer, including brisk walking, lycopene intake, increased fruit vegetable intake reduced dairy consumption. However, randomised controlled trial data limited. The ‘Prostate Cancer: Evidence Exercise Nutrition Trial’ investigates the feasibility recruiting randomising diagnosed localised cancer eligible radical prostatectomy to modify nutrition activity. primary randomisation rates adherence at 6 months following randomisation. secondary intervention tolerability, retention, change in specific antigen level, diet, general levels, insulin-like growth factor a range related outcomes, quality life measures. is factorial, both (brisk walking or control) (lycopene supplementation vegetables consumption intervention. has two phases: enrolled into cohort study prior prostatectomy, then consented after trial. Data collected four time points (cohort baseline, true baseline 3 post-randomisation). Prostate Trial aims determine whether who scheduled can be recruited subsequently 6-month If successful, this will inform larger investigate population gain clinical benefit from long-term post-surgery. (PrEvENT) registered on ISRCTN registry, ref number ISRCTN99048944. Date registration 17 November 2014.