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


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Lucy Hackshaw-McGeagh1,Chris Penfold1,Ellie Shingler2,Athene Lane2,Richard Martin1
1University of Bristol,2University of bristol



Dietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate cancer.


Patients were recruited into a pre-surgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2x3 factorial randomised controlled trial (RCT). Patients were recruited from a single National Health Service trust in the South West of England, UK; All those with localised prostate cancer and listed for radical prostatectomy were invited to participate. Random allocation was performed by the Bristol Randomised Trial Collaboration via an online system. 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. Only the trial statistician was blind to allocations. Primary outcome measures were 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.


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.


Interventions were deemed feasible, with high randomisation rates and good adherence. A definitive RCT is proposed.