McGeagh Lucy, Robles Luke A, Persad Raj, Rowe Edward, Bahl Amit, Aning Jonathan, Koupparis Anthony, Abrams Paul, Perks Claire, Holly Jeffrey, Johnson Lyndsey, Shiridzinomwa Constance, Challapalli Amarnath, Shingler Ellie, Taylor Hilary, Oxley Jon, Sandu Meda, 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.
Supportive Cancer Care Research Group, Faculty of Health and Life Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.
Pilot Feasibility Stud. 2022 Aug 12;8(1):179. doi: 10.1186/s40814-022-01136-7.
Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life.
Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up.
Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions.
Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.
观察性研究的证据表明，中等强度的体育活动可降低前列腺癌患者病情进展风险及癌症特异性死亡率。流行病学研究还表明，服用二甲双胍的参与者患前列腺癌的风险降低。然而，支持使用这些干预措施的随机对照试验数据有限。前列腺癌-运动与二甲双胍试验旨在研究将被诊断为局限性或局部晚期前列腺癌的参与者随机分配至可改变体育活动和血糖水平的干预措施的可行性。主要结局指标为随机分组率以及6个月内对干预措施的依从性。次要结局指标包括干预耐受性和保留率、胰岛素样生长因子I、前列腺特异性抗原、体育活动、症状报告及生活质量的测量指标。
参与者按2×2析因设计随机分配至体育活动（快走或对照）和药物（二甲双胍或对照）干预组。参与者进行6个月的干预，并在12个月随访时收集最终测量数据。
我们的试验将确定那些计划接受根治性治疗或正在监测癌症进展迹象的被诊断为局限性或局部晚期前列腺癌的参与者是否可随机分配至为期6个月的体育活动和二甲双胍干预。我们试验的结果将为一项规模更大的试验提供信息，该试验旨在检验这些干预措施的临床益处。
前列腺癌运动与二甲双胍试验（Pre-EMpT）已在国际标准随机对照试验编号注册库注册，注册号为ISRCTN13543667。注册日期为2018年8月2日——追溯注册。第一名参与者于2018年9月11日招募。
