The Exercise And Colorectal Cancer Treatment Trial

Not Applicable

Active, not recruiting

• Conditions: Rectal Cancer; Colon Cancer
• Interventions: Behavioral: Moderate-Intensity Aerobic Exercise; Behavioral: Wait-List Control

• Registration Number: NCT03975491
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Study Start: 2019-08-16
• Status Verified: 2024-06
• Primary Completion: 2024-06-01
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise	Moderate-Intensity Aerobic Exercise	Moderate-intensity aerobic exercise
Control	Wait-List Control	Wait-list control

Primary Outcome Measures

Name	Time	Method
Interleukin-6	Baseline, 12 weeks	Concentration of interleukin-6 (pg/mL)
High Sensitivity C-Reactive Protein	Baseline, 12 weeks	Concentration of high-sensitivity C-reactive protein (mg/L)

Secondary Outcome Measures

Name	Time	Method
Soluble Tumor Necrosis Factor-Alpha Receptor Two	Baseline, 12 weeks	Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)
Insulin Resistance	Baseline, 12 weeks	Oral Glucose Tolerance Test (2 hour AUC)
Circulating Tumor Cells	Baseline, 12 weeks	Concentration of circulating tumor cells (cells per mL whole blood)

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States