A Study on the Effects of Exercise on Side Effects From Treatment for Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.

Official Title
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Dose-response of Aerobic Training During Neoadjuvant Chemotherapy for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: structured treadmill walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years Diagnosed with colorectal cancer as defined by one of the following: Histological confirmation As per standard of care imaging Scheduled to receive neoadjuvant chemotherapy Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire Exclusion Criteria: Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes Receiving treatment for any other diagnosis of invasive cancer Distant metastatic malignancy of any kind Mental impairment leading to inability to cooperate Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 90 min/wk<br>AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. | Behavioral: structured treadmill walking<br>* Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from chemotherapy initiation until surgery ( 32 weeks).<br>|
| Experimental: 150 mins/wk<br>AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. | Behavioral: structured treadmill walking<br>* Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from chemotherapy initiation until surgery ( 32 weeks).<br>|
| Experimental: 300 mins/wk<br>AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. | Behavioral: structured treadmill walking<br>* Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from chemotherapy initiation until surgery ( 32 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% | RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity). | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, 22-164