Morielli Andria R, Usmani Nawaid, Boulé Normand G, Severin Diane, Tankel Keith, Nijjar Tirath, Joseph Kurian, Fairchild Alysa, Courneya Kerry S
Faculty of Kinesiology, Sport, and Recreation, University of Alberta, 1-113 University Hall, Van Vliet Complex, Edmonton, AB, T6G 2H9, Canada.
Department of Oncology, University of Alberta and Cross Cancer Institute, 11560 University Avenue, Edmonton, AB, T6G 1Z2, Canada.
Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.
Standard treatment for locally advanced rectal cancer includes 5-6 weeks of neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision 6-8 weeks later. NACRT improves local disease control and surgical outcomes but also causes side effects including fatigue, diarrhea, hand-foot syndrome, and physical deconditioning that may impede quality of life (QoL), treatment completion, treatment response, and long-term prognosis. Interventions to improve treatment outcomes and manage side effects that are safe, tolerable and low-cost are highly desirable. Exercise has been shown to improve some of these outcomes in other cancer patient groups but no study to date has examined the potential benefits (and harms) of exercise training during and after NACRT for rectal cancer.
METHODS/DESIGN: The Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT) trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness assessed by the Senior's Fitness Test, QoL assessed by the European Organisation of Research and Treatment of Cancer, and symptom management assessed by the M.D. Anderson Symptom Inventory. Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.
If the preliminary findings of EXERT are positive, additional research will be warranted to confirm whether exercise is an innovative treatment to maintain QoL, manage side effects, and/or improve treatment outcomes in rectal cancer patients.
ClinicalTrials.gov, ID: NCT03082495 . Registered on 9 February, 2017.
局部晚期直肠癌的标准治疗包括5 - 6周的新辅助放化疗（NACRT），随后在6 - 8周后进行全直肠系膜切除术。NACRT可改善局部疾病控制和手术效果，但也会引起副作用，包括疲劳、腹泻、手足综合征和身体机能下降，这些可能会影响生活质量（QoL）、治疗完成情况、治疗反应和长期预后。非常需要采取安全、可耐受且低成本的干预措施来改善治疗效果和管理副作用。运动已被证明可改善其他癌症患者群体的一些上述结果，但迄今为止尚无研究探讨直肠癌患者在NACRT期间及之后进行运动训练的潜在益处（和危害）。
方法/设计：新辅助直肠癌治疗期间及之后的运动（EXERT）试验是一项单中心、前瞻性、双臂、II期随机对照试验，旨在测试运动训练在该临床环境中的初步疗效，并进一步评估其可行性和安全性。参与者将为60例计划接受长疗程NACRT并随后进行全直肠系膜切除术的直肠癌患者。参与者将被随机分配至运动训练组或常规治疗组。运动训练组的参与者将被要求在NACRT期间每周完成三次有监督的高强度间歇训练课程，并在NACRT后手术前每周进行≥150分钟的无监督中等至高强度持续运动训练。常规治疗组的参与者将被要求不要比基线增加运动量。评估将在NACRT前、NACRT后和手术前完成。主要终点将是通过分级运动试验评估的NACRT后时间点的心肺适能（VO峰值）。次要终点将包括通过老年人适能测试评估的功能适能、通过欧洲癌症研究与治疗组织评估的QoL以及通过MD安德森症状量表评估的症状管理。探索性临床终点将包括治疗毒性、治疗完成情况、治疗反应和手术并发症。
如果EXERT的初步结果为阳性，则有必要进行更多研究以确认运动是否是一种创新治疗方法，可维持直肠癌患者的QoL、管理副作用和/或改善治疗效果。
ClinicalTrials.gov，ID：NCT03082495。于2017年2月9日注册。
