Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Department of Nursing, The University of Melbourne, Melbourne, Victoria, Australia.
BMJ Open. 2020 Feb 28;10(2):e036059. doi: 10.1136/bmjopen-2019-036059.
There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue.
Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning.
This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients.
ACTRN12619000952145; Pre-results.
越来越多的证据表明，运动在对抗癌症治疗相关疲劳方面具有益处。免疫疗法是一种已被证实的晚期黑色素瘤治疗方法，约三分之一的患者会出现疲劳症状。目前尚不清楚运动对于接受免疫治疗的晚期黑色素瘤患者在对抗治疗相关疲劳方面的安全性和有效性。本研究旨在评估由运动生理学家（iMove）制定的个性化、为期 12 周的半监督运动方案的安全性、患者依从性和可接受性，该方案适用于 30 名计划开始免疫治疗的 IV 期黑色素瘤患者：单药伊匹单抗、纳武单抗或派姆单抗，或伊匹单抗联合纳武单抗。该试验将用于提供运动管理疲劳的潜在疗效的初步证据。
2019 年 5 月至 9 月，将从一家癌症专科中心招募 30 名参与者。参与者将按照 1:1 的比例随机分为 iMove 组或常规护理组（一份关于癌症患者运动的信息手册）。可行性数据包括：合格性；招募和保留率；对运动咨询、个性化运动方案和研究措施的依从性和可接受性；以及与运动相关的不良事件。患者报告的结果测量指标评估运动干预对以下方面的潜在影响：疲劳、角色功能、症状和生活质量。随访将包括 24 周内的 5 个时间点。身体评估测量身体适应性和功能。
本研究已由彼得·麦卡勒姆癌症中心人体研究伦理委员会（HREC/48927/PMCC-2019）审查和批准。本试验的结果将通过会议演讲和同行评议期刊发表以及与临床医生、媒体、政府和消费者的接触进行传播。特别是，如果这项试验结果表明对患者有益，我们将在肿瘤学领域推广这项工作的结果。
ACTRN12619000952145；预结果。
