Robert U. Newton, Edith Cowan UniversityFollow
Claus T. Christophersen, Edith Cowan UniversityFollow
Ciaran M. Fairman, Edith Cowan UniversityFollow
Nicolas H. Hart, Edith Cowan UniversityFollow
Dennis R. Taaffe, Edith Cowan UniversityFollow
David Broadhurst, Edith Cowan UniversityFollow
Amanda Devine, Edith Cowan UniversityFollow
Raphael Chee, Edith Cowan UniversityFollow
Colin I. Tang
Nigel Spry, Edith Cowan UniversityFollow
Daniel A. Galvão, Edith Cowan UniversityFollow
BMJ Publishing Group Ltd
School of Medical and Health Sciences
This study is funded by Prostate Cancer Foundation Australia (PCFA), New Concepts Grant scheme. NHH is supported by Cancer Council Western Australia Postdoctoral Fellowship. DRT and DB are supported by Professorial Research Fellowships of Edith Cowan University. CMF is supported by an NHMRC Centre of Research Excellence (Prostate Cancer Survivorship) Postdoctoral Fellowship
Introduction: A potential link exists between prostate cancer (PCa) disease and treatment and increased inflammatory levels from gut dysbiosis. This study aims to examine if exercise favourably alters gut microbiota in men receiving androgen deprivation therapy (ADT) for PCa. Specifically, this study will explore whether: (1) exercise improves the composition of gut microbiota and increases the abundance of bacteria associated with health promotion and (2) whether gut health correlates with favourable inflammatory status, bowel function, continence and nausea among patients participating in the exercise intervention.
Methods and analysis: A single-blinded, two-armed, randomised controlled trial will explore the influence of a 3-month exercise programme (3 days/week) for men with high-risk localised PCa receiving ADT. Sixty patients will be randomly assigned to either exercise intervention or usual care. The primary endpoint (gut health and function assessed via feacal samples) and secondary endpoints (self-reported quality of life via standardised questionnaires, blood biomarkers, body composition and physical fitness) will be measured at baseline and following the intervention. A variety of statistical methods will be used to understand the covariance between microbial diversity and metabolomics profile across time and intervention. An intention-to-treat approach will be utilised for the analyses with multiple imputations followed by a secondary sensitivity analysis to ensure data robustness using a complete cases approach.
Ethics and dissemination: Ethics approval was obtained from the Human Research Ethics Committee of Edith Cowan University (ID: 19827 NEWTON). Findings will be reported in peer-reviewed publications and scientific conferences in addition to working with national support groups to translate findings for the broader community. If exercise is shown to result in favourable changes in gut microbial diversity, composition and metabolic profile, and reduce gastrointestinal complications in PCa patients receiving ADT, this study will form the basis of a future phase III trial.
Trial registration number ANZCTR12618000280202.
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