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

Abstract

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

The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study

“…This contact was made via phone, email or post, depending on participant preferences, and provided motivational messages and resources such as recipes to encourage continued participation in the intervention. Full details of the PrEvENT interventions have been described in detail elsewhere [12]. The third phase of the trial involved semi-structured interviews with participants to explore their attitudes and views about the behavioural change modification and participation in the trial.…”

Functional Training Protocol in Men with Prostate Cancer: A Non-Randomized Clinical Trial

“…In addition to decreasing fatigue and depression-related symptoms, physical activity improves self-esteem, sexual satisfaction, and fitness. Previous studies have evaluated walking protocols [12] and aerobic exercises combined with resistance exercises [23] in men with cancer. Other studies have evaluated interventions that were not validated, including walking [19], aerobic training [14,17], and pelvic floor exercise [19], as well as support groups to improve quality-of-life [13,16].…”

Phase II randomised control feasibility trial of a nutrition and physical activity intervention after radical prostatectomy for prostate cancer

“…The trial protocol has been published elsewhere 17. In brief, men from a single National Health Service trust in the South West of England, UK, who were diagnosed with localised prostate cancer and listed for radical prostatectomy, were invited to participate in PrEvENT between August 2014 and May 2016.…”