Exercise During and After Neoadjuvant Rectal Cancer Treatment

Study Overview
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Brief Summary
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This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.

Detailed Description
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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.

Official Title
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A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy

Conditions
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Rectal Cancer

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Aerobic exercise | Behavioral: Exercise<br>* 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<br>|
| No Intervention: Usual Care<br>Standard medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiorespiratory fitness | VO2 peak | pre-NACRT (baseline), post-NACRT (an average of 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness | VO2 peak | pre-surgery (an average of 12 weeks) | 
| Functional fitness | Senior's Fitness Test | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Generic quality of life | European Organisation for Research and Treatment of Cancer core 30-item questionnaire | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Disease specific quality of life | European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Symptom burden | M.D. Anderson Symptom Inventory | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Exercise motivation | Theory of planned behaviour | pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Eligibility rate | Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT | up to 20 months | 
| Recruitment rate | Number of patients randomized divided by the number of eligible patients | up to 20 months | 
| Exercise adherence rate | 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. | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Follow-up assessment rate | 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. | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 
| Safety: Adverse event rate | Number of serious adverse events that occur during exercise testing or the supervised exercise sessions | post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Cancer, Symptom management, Quality of life, presurgical, chemoradiotherapy, Physical Fitness