Exercise During and After Neoadjuvant Rectal Cancer Treatment

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Behavioral: Exercise

• Registration Number: NCT03082495
• Lead Sponsor: University of Alberta

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-17
• Study Start: 2017-06-26
• Primary Completion: 2019-10-17
• Study Completion: 2020-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Aerobic exercise

Primary Outcome Measures

Name	Time	Method
Change in Cardiorespiratory fitness	pre-NACRT (baseline), post-NACRT (an average of 6 weeks)	VO2 peak

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada