Article Text
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 presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 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 6 months.
Blinding Only the trial statistician was blind to allocations.
Primary outcome measures Primary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%.
Results 108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 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 generally good adherence. A definitive RCT is proposed.
Trial registration number ISRCTN 99048944.
- prostate disease
- urology
- clinical trials
- surgery
- preventive medicine
- urological tumours
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Footnotes
Contributors LEHM conceived and designed the work, acquired and interpreted data and drafted the manuscript. CP interpreted data and drafted the manuscript. ES and LAR acquired data. CMP, JMPH, ER, AK, AB and RP designed the work. CS, LJ, KMB and AF acquired data. JVW and SG interpreted data. JO and PA designed the work. JAL and RMM conceived the work, designed the work and interpreted data. All authors revised the manuscript, approved the final version of the manuscript and agree to be accountable for all aspects of the work.
Funding This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The Bristol Randomised Trials Collaboration (BRTC) receives National Institute for Health Research CTU Support Funding. The BRTC is a UK Clinical Research Collaboration registered CTU and a member of the NCRI Cancer Clinical Trials Group.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The trial was performed in accordance with the Declaration of Helsinki, and the ethical principles of the International Conference on Harmonisation – Good Clinical Practice. All study procedures were approved by the National Research Ethics Committee South West – Cornwall and Plymouth (REC reference number 14/SW/0056). All men provided fully informed written consent at both the cohort and RCT recruitment stages. The trial was registered with the ISRCTN registry on 17 November 2014 (ISRCTN99048944).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.