The Exercise And Colorectal Cancer Treatment Trial (EXACT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Moderate-Intensity Aerobic Exercise; Behavioral: Wait-List Control

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin LeJeune; Phone Number: 225-763-2706; Email: erin.lejeune@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise; Moderate-intensity aerobic exercise	Behavioral: Moderate-Intensity Aerobic Exercise; 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.
Sham Comparator: Control; Wait-list control	Behavioral: Wait-List Control; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Fraction	Proportion of Circulating Tumor DNA (relative to all cell-free DNA)	Baseline, 12 weeks
Mitochondrial Respiration Rate	Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)	Baseline, 12 weeks
Fatty Acid Oxidation	Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Justin C Brown, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): May 16, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PBRC 2019-009; R00CA218603 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
• IPD Sharing Time Frame: After reporting and publication of the primary, secondary, and exploratory study outcomes is complete.
• IPD Sharing Access Criteria: Data will be shared according to the principles outlined by Tudur Smith et al in BMC Medicine 2015.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No