Exercise and Colon Cancer

Study Overview
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Brief Summary
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Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.

Official Title
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The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study

Conditions
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Stage II Colon Cancer, Stage III Colon Cancer

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed TNM stage II-III CC; completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study; ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire; age ≥18 years; written physician approval; no additional surgery planned within the 6-month intervention (including colostomy reversal); ability to walk unaided for 6-minutes; no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication. Exclusion Criteria: history of another primary invasive cancer (other than non-melanoma skin-cancer); evidence of metastatic CC (i.e., TNM M1); planning to receive any additional adjuvant chemotherapy; pregnant or breast feeding; unable to provide baseline blood sample; cardiac conditions, including the following: myocardial infarction or coronary revascularization procedure within prior 3 months; uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg); high-risk or uncontrolled arrhythmias; clinically significant valvular disease; decompensated heart failure; known aortic aneurysm; any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).

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
Intervention Model: Single Group Assignment
Interventional Model Description: exercise


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>aerobic exercise on soluble intercellular adhesion molecules | Other: Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study; |  | 6 months | 
| Visceral adipose tissue and anthropometric measures at baseline and six-months; |  | 6 months | 
| Fasting insulin measured at baseline and six-months; |  | six months | 
| Circulating tumor cells measured at baseline and six-months. |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer