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.
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 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.
ANZCTR12618000280202.
BMJ open. 2019 Apr 14*** epublish ***
Robert U Newton, Claus T Christophersen, Ciaran M Fairman, Nicolas H Hart, Dennis R Taaffe, David Broadhurst, Amanda Devine, Raphael Chee, Colin I Tang, Nigel Spry, Daniel A Galvão
Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia., School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia., School of Science, Edith Cowan University, Perth, Western Australia, Australia., Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.