Robles Luke A, McGeagh Lucy, Aning Jonathan, Bahl Amit, Challapalli Amarnath, Koupparis Anthony, Persad Raj, Rowe Edward, Shiridzinomwa Constance, Martin Richard M, Lane J Athene
NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.
Pilot Feasibility Stud. 2025 May 24;11(1):71. doi: 10.1186/s40814-025-01654-0.
Moderate to vigorous physical activity and metformin are associated in epidemiological studies with reduced biochemical recurrence and mortality in men with prostate cancer. This study assessed the feasibility of a home-based physical activity and/or metformin intervention in men with non-metastatic prostate cancer following radical treatment (surgery or radiotherapy) or active surveillance.
A 2 × 2 factorial design randomised men into one of four groups for 6 months: (1) physical activity (defined as brisk walking ≥ 30 min for ≥ 5 days per week, aiming for ≥ 10,000 steps a day); (2) metformin (one 500 mg slow-release tablet daily); (3) physical activity and metformin; and (4) control. Men were recruited from a single tertiary referral centre in the South West of England, UK, (September 2018-March 2020 which terminated slightly early due to the COVID-19 pandemic). Co-primary outcomes were rates of randomisation and adherence which was defined as men brisk walking ≥30 minutes on at least 5 days with 10,000 steps daily (measured over one week 6-months after randomisation) with ≥ 60% adherence to metformin between 3- and 6 months post-randomisation using returned pill count. Secondary outcomes included self-reported adverse events and physical activity, feasibility of wearing activity monitors and questionnaire completion.
In total, 295 men were eligible and 110 were randomised (37.3%, 95% confidence interval [CI] 31.8 to 43.1). Adherence to the physical activity and metformin interventions was 46.9% (95% CI 32.5 to 62.0) and 47.1% (95% CI 32.9 to 61.5) respectively. Adherence was > 60% for both the physical activity and metformin interventions on a complete case basis. Adverse events were infrequent (n = 7) across randomised groups. Completion of self-reported measures of physical activity, urinary incontinence, sexual function, quality of life and stages of change was over 80%. Step counts were not higher in men wearing activity monitors that alerted them about their step counts and sedentary behaviour. Retention over 6 months was 91.3% (95% CI 84.2 to 96.0). Follow up and intervention prompts were impacted by the pandemic.
Home-based physical activity and metformin interventions show some promise for men with prostate cancer following radical treatment or active surveillance.
ISRCTN, ISRCTN13543667. Registered 2 August 2018, https://www.isrctn.com/ISRCTN13543667.
在流行病学研究中，中度至剧烈体力活动和二甲双胍与前列腺癌男性患者生化复发率降低及死亡率降低相关。本研究评估了在接受根治性治疗（手术或放疗）或主动监测后的非转移性前列腺癌男性患者中，进行居家体力活动和/或二甲双胍干预的可行性。
采用2×2析因设计，将男性患者随机分为四组，为期6个月：（1）体力活动组（定义为每周至少5天快走≥30分钟，目标是每天步数≥10000步）；（2）二甲双胍组（每天服用1片500毫克缓释片）；（3）体力活动和二甲双胍组；（4）对照组。研究对象来自英国英格兰西南部的一个单一三级转诊中心（2018年9月至2020年3月，由于新冠疫情提前结束）。共同主要结局是随机分组率和依从性，依从性定义为男性在随机分组后6个月内至少5天快走≥30分钟且每天步数达10000步（在随机分组后1周测量），以及在随机分组后3至6个月使用返还药片计数法，二甲双胍的依从率≥60%。次要结局包括自我报告的不良事件和体力活动情况、佩戴活动监测器的可行性以及问卷完成情况。
共有295名男性符合条件，110名被随机分组（37.3%，95%置信区间[CI]为31.8%至43.1%）。体力活动和二甲双胍干预的依从率分别为46.9%（95%CI为32.5%至62.0%）和47.1%（95%CI为32.9%至61.5%）。在完整病例基础上，体力活动和二甲双胍干预的依从率均>60%。各随机分组组的不良事件较少（n = 7）。自我报告的体力活动、尿失禁、性功能、生活质量和行为改变阶段的测量完成率超过80%。佩戴可提醒步数和久坐行为的活动监测器的男性，其步数并未更高。6个月时的保留率为91.3%（95%CI为84.2%至96.0%）。随访和干预提示受到疫情影响。
对于接受根治性治疗或主动监测后的前列腺癌男性患者，居家体力活动和二甲双胍干预显示出一定前景。
ISRCTN，ISRCTN13543667。2018年8月2日注册，https://www.isrctn.com/ISRCTN13543667 。
