The Exercise And Colorectal Cancer Treatment Trial

The Exercise And Colorectal Cancer Treatment (EXACT) Trial

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

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 and interleukin-6. 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 in peripheral blood mononuclear cells and tumor fraction.

Inclusion Criteria:

• Age ≥18 years
• Histologically-confirmed stage I-III colorectal cancer
• Completed surgical resection
• Completed chemotherapy (if applicable)
• Completed radiotherapy (if applicable)
• 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
• 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)