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Publication - Professor Jeffrey Holly

    PHASE II RANDOMISED CONTROL FEASIBILITY TRIAL OF A NUTRITION AND PHYSICAL ACTIVITY INTERVENTION AFTER RADICAL PROSTATECTOMY FOR PROSTATE CANCER

    Citation

    Hackshaw-McGeagh, L, Penfold, C, Shingler, E, Robles, LA, Perks, CM, Holly, JMP, Rowe, E, Koupparis, AJ, Bahl, A, Persad, RA, Shiridzinomwa, C, Johnson, L, Biernacka, K, Frankow, A, Woodside, JV, Gilchrist, S, Abrams, PH, Lane, JA & Martin, RM, 2019, ‘PHASE II RANDOMISED CONTROL FEASIBILITY TRIAL OF A NUTRITION AND PHYSICAL ACTIVITY INTERVENTION AFTER RADICAL PROSTATECTOMY FOR PROSTATE CANCER’. BMJ Open.

    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.

    Full details in the University publications repository