The Exercise And Colorectal Cancer Treatment Trial

Study Overview
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Brief Summary
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This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.

Detailed Description
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This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein, interleukin-6, and soluble tumor necrosis factor-alpha receptor two. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation.

Official Title
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The Exercise And Colorectal Cancer Treatment (EXACT) Trial

Conditions
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Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Behavioral: Moderate-Intensity Aerobic Exercise
* Behavioral: Wait-List Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Histologically-confirmed stage I-III colorectal cancer Completed surgical resection Completed chemotherapy (if applicable) Completed radiotherapy (if applicable) Self-report, on average over the past one-month, less than or 90 minutes per week of moderate-intensity or vigorous-intensity physical activity Provide written approval by physician or other qualified healthcare provider No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted) Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q) Allow the collection and storage of specimens and data for future use 1.10 Willing to be randomized Exclusion Criteria: Evidence of metastatic colon cancer Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers) Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention Current body mass greater than or equal to 181 kg Unable to provide a baseline fasting blood sample Unable or unwilling to give informed consent Unable or unwilling to be randomized Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br>Moderate-intensity aerobic exercise | Behavioral: Moderate-Intensity Aerobic Exercise<br>* The exercise intervention will consist of moderate-intensity (50-70% age-predicted maximum heart rate) treadmill walking. All exercise sessions will begin with a five-minute warm up of slow walking, 30-60 minutes of moderate-intensity walking, and a five-minute cool down of slow walking.<br>|
| Sham Comparator: Control<br>Wait-list control | Behavioral: Wait-List Control<br>* Participants randomized into the wait-list control group are asked to maintain their pre-study levels of physical activity and follow the recommendations provided by their physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Sensitivity C-Reactive Protein | Concentration of high-sensitivity C-reactive protein (mg/L) | Baseline, 12 weeks | 
| Interleukin-6 | Concentration of interleukin-6 (pg/mL) | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soluble Tumor Necrosis Factor-Alpha Receptor Two | Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL) | Baseline, 12 weeks | 
| Insulin Resistance | Oral Glucose Tolerance Test (2 hour AUC) | Baseline, 12 weeks | 
| Circulating Tumor Cells | Concentration of circulating tumor cells (cells per mL whole blood) | Baseline, 12 weeks | 
| Tumor Fraction | Proportion of Circulating Tumor DNA (relative to all cell-free DNA) | Baseline, 12 weeks |