Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Study Overview
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Brief Summary
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To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

Official Title
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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: Progressive stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Histologically confirmed stage II or III colon cancer Completed surgical resection with curative intent Plan to initiate an oxaliplatin-based chemotherapy regimen Engage in <60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise No planned major surgery during the study period Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire Can walk 400 meters Can read and speak English Ability to provide written informed consent Provide written approval by qualified healthcare professional Willing to be randomized Exclusion Criteria: Evidence of metastatic colon cancer Concurrently actively treated other (non-colon) cancer Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks Currently participating in another study with competing outcomes Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Attention control<br>Static stretching | Behavioral: Progressive stretching<br>* Static stretching of eight major muscle groups<br>|
| Experimental: 75 min/wk aerobic exercise<br>Aerobic exercise at a dose of 75 minutes per week | Behavioral: Aerobic exercise<br>* Moderate- to vigorous-intensity aerobic exercise<br>|
| Experimental: 150 min/wk aerobic exercise<br>Aerobic exercise at a dose of 150 minutes per week | Behavioral: Aerobic exercise<br>* Moderate- to vigorous-intensity aerobic exercise<br>|
| Experimental: 225 min/wk aerobic exercise<br>Aerobic exercise at a dose of 225 minutes per week | Behavioral: Aerobic exercise<br>* Moderate- to vigorous-intensity aerobic exercise<br>|
| Experimental: 300 min/wk aerobic exercise<br>Aerobic exercise at a dose of 300 minutes per week | Behavioral: Aerobic exercise<br>* Moderate- to vigorous-intensity aerobic exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy Relative Dose Intensity | The ratio of the delivered dose intensity to the standard or planned dose intensity. | 12- or 24-weeks |