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

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Original languageEnglish
Article numbere029480
Number of pages11
JournalBMJ Open
Volume9
Issue number11
DOIs
DateAccepted/In press - 14 Aug 2019

Abstract

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

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.

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    Rights statement: This is the final published version of the article (version of record). It first appeared online via BMJ at https://bmjopen.bmj.com/content/9/11/e029480. Please refer to any applicable terms of use of the publisher.

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