Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT03975491
This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Oral Glucose Tolerance Test (2 hour AUC)
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)
Time frame: Baseline, 12 weeks
Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)
Pennington Biomedical Research Center
Other
The Exercise And Colorectal Cancer Treatment (EXACT) Trial
Acronym: EXACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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