The Exercise And Colorectal Cancer Treatment Trial (EXACT)

September 2, 2025 updated by: Justin Brown, Pennington Biomedical Research Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame
The Percentage Change in High-sensitivity C-reactive Protein
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
The Percentage Change in Interleukin-6
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Resistance
Time Frame: Baseline, 12 weeks
Oral Glucose Tolerance Test (2 hour AUC)
Baseline, 12 weeks
The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
The Change in Circulating Tumor Cells Per mL Whole Blood
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitochondrial Respiration Rate
Time Frame: Baseline, 12 weeks
Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)
Baseline, 12 weeks
Fatty Acid Oxidation
Time Frame: Baseline, 12 weeks
Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)
Baseline, 12 weeks
The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA)
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Justin C Brown, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

May 1, 2023

Study Completion (Estimated)

January 1, 2026

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 (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Moderate-Intensity Aerobic Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe