A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Cardiorespiratory fitness
研究概览
简要总结
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
排除标准
- •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
研究组 & 干预措施
Exercise
Aerobic exercise
干预措施: Exercise (Behavioral)
Usual Care
Standard medical care
结局指标
主要结局
Change in Cardiorespiratory fitness
时间窗: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
VO2 peak
次要结局
- Cardiorespiratory fitness(pre-surgery (an average of 12 weeks))
- Functional fitness(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Generic quality of life(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Disease specific quality of life(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Symptom burden(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Exercise motivation(pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Eligibility rate(up to 20 months)
- Recruitment rate(up to 20 months)
- Exercise adherence rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Follow-up assessment rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))
- Safety: Adverse event rate(post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks))