Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.
School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.
BMJ Open. 2019 Apr 14;9(4):e024872. doi: 10.1136/bmjopen-2018-024872.
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.
前列腺癌（PCa）疾病及其治疗与肠道菌群失调引起的炎症水平升高之间存在潜在联系。本研究旨在研究运动是否会对接受雄激素剥夺治疗（ADT）的 PCa 男性的肠道微生物群产生有利影响。具体来说，本研究将探讨：（1）运动是否改善肠道微生物群的组成并增加与健康促进相关的细菌丰度，以及（2）肠道健康是否与患者参与运动干预后的有利炎症状态、肠道功能、控便能力和恶心相关。
一项单盲、双臂、随机对照试验将探索为期 3 个月的运动计划（每周 3 天）对接受 ADT 的高危局限性 PCa 男性的影响。60 名患者将被随机分配到运动干预组或常规护理组。主要终点（通过粪便样本评估肠道健康和功能）和次要终点（通过标准问卷、血液生物标志物、身体成分和身体适应性评估自我报告的生活质量）将在基线和干预后进行测量。将使用多种统计方法来了解微生物多样性和代谢组学特征随时间和干预的协方差。将使用意向治疗方法进行分析，并采用多次插补法进行敏感性分析，以使用完整病例方法确保数据稳健性。
伊迪丝·考恩大学人类研究伦理委员会（ID：19827 NEWTON）已批准该研究。研究结果将在同行评议的出版物和科学会议上报告，此外还将与国家支持团体合作，将研究结果转化为更广泛的社区。如果运动被证明会导致 ADT 治疗的 PCa 患者肠道微生物多样性、组成和代谢谱的有利变化，并减少胃肠道并发症，那么这项研究将为未来的 III 期试验奠定基础。
ANZCTR12618000280202。
