Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)
2022年5月24日 更新者：University of Alberta
A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
研究概览
详细说明
The 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 (VO2 peak) at the post-NACRT time point assessed by a graded exercise test.
Secondary endpoints will include functional fitness, quality of life, and symptom management.
Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
Exclusion Criteria:
- Unable to consent
- Unable to perform aerobic exercise
- Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：锻炼
有氧运动
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Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery
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无干预：Usual Care
Standard medical care
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Cardiorespiratory fitness
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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VO2 peak
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiorespiratory fitness
大体时间：pre-surgery (an average of 12 weeks)
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VO2 peak
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pre-surgery (an average of 12 weeks)
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Functional fitness
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Senior's Fitness Test
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Generic quality of life
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer core 30-item questionnaire
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Disease specific quality of life
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Symptom burden
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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M.D. Anderson Symptom Inventory
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise motivation
大体时间：pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Theory of planned behaviour
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Eligibility rate
大体时间：up to 20 months
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Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT
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up to 20 months
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Recruitment rate
大体时间：up to 20 months
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Number of patients randomized divided by the number of eligible patients
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up to 20 months
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Exercise adherence rate
大体时间：post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise adherence during NACRT will be assessed by the number of exercise sessions attended out of 18 as well as adherence to the intensity and duration of the HIT intervals.
Exercise adherence to the unsupervised exercise after NACRT will be assessed by self-report using the Godin Leisure-Time Exercise.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Follow-up assessment rate
大体时间：post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of patients in each group completing the objective outcomes (cardiorespiratory fitness and functional fitness) and patient-reported outcomes (quality of life, symptom burden) at each timepoint.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Safety: Adverse event rate
大体时间：post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of serious adverse events that occur during exercise testing or the supervised exercise sessions
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment toxicities
大体时间：every week during NACRT (up to 6 weeks)
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CTCAE Version 3.0
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every week during NACRT (up to 6 weeks)
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Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
大体时间：post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Number of patients receiving ≥ 80% of their planned chemotherapy dose
大体时间：post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Pathologic complete response rate
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Length of hospital stay
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Surgical approach
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Ostomy
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Sphincter preservation
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Blood loss
大体时间：post-surgery (an average of 12 weeks)
|
Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
|
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Number of positive lymph nodes
大体时间：post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
|
post-surgery (an average of 12 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kerry S Courneya, PhD、University of Alberta
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Joseph K, Nijjar T, Fairchild A, Courneya KS. Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial. Clin Colorectal Cancer. 2021 Sep;20(3):216-226. doi: 10.1016/j.clcc.2021.05.004. Epub 2021 May 26.
- Morielli AR, Boule NG, Usmani N, Tankel K, Joseph K, Severin D, Fairchild A, Nijjar T, Courneya KS. Effects of exercise during and after neoadjuvant chemoradiation on symptom burden and quality of life in rectal cancer patients: a phase II randomized controlled trial. J Cancer Surviv. 2021 Nov 29. doi: 10.1007/s11764-021-01149-w. Online ahead of print.
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Nijjar T, Joseph K, Fairchild A, Courneya KS. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial. Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月26日
初级完成 (实际的)
2019年10月17日
研究完成 (实际的)
2020年9月1日
研究注册日期
首次提交
2017年2月9日
首先提交符合 QC 标准的
2017年3月10日
首次发布 (实际的)
2017年3月17日
研究记录更新
最后更新发布 (实际的)
2022年5月27日
上次提交的符合 QC 标准的更新
2022年5月24日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的