Design: Patients were recruited into a pre-surgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2x3 factorial randomised controlled trial (RCT).
Setting: A single National Health Service trust in the South West of England, UK.
Participants: Those with localised prostate cancer and listed for radical prostatectomy were invited to participate.
Randomisation: Random allocation was performed by the Bristol Randomised Trial Collaboration via an online system.
Interventions: Men were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control), for six months.
Blinding: Only the trial statistician was blind to allocations.
Primary outcome measures: Collected at trial baseline, three and six months, with daily adherence reported throughout. Primary outcomes were measures of feasibility: randomisation rates and intervention adherence at six months.
Results: 108 men entered the pre-surgical cohort and 81 were randomised into the post-surgical RCT (randomisation rate: 93.1%), 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI: 23.4%-59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0% 95% CI 52.4%-85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI: 60.5%-89.8%), whilst 21/39 adhered to the walking intervention (53.8%; 95% CI: 38.6%-68.4%). Most men were followed up at six months (75/81; 92.6%). Three “possibly related” adverse events were indigestion, abdominal bloating and knee pain.
Conclusions: Interventions were deemed feasible, with high randomisation rates and good adherence. A definitive RCT is proposed.
- BTC (Bristol Trials Centre)