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NCT Number: NCT03975491

The Exercise And Colorectal Cancer Treatment Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Moderate-intensity aerobic exercise

Behavioral

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.

Wait-list control

Behavioral

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.

Primary outcomes

  1. The Percentage Change in High-sensitivity C-reactive Protein

    Time frame: Baseline, 12 weeks

  2. The Percentage Change in Interleukin-6

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two

    Time frame: Baseline, 12 weeks

  2. The Change in Circulating Tumor Cells Per mL Whole Blood

    Time frame: Baseline, 12 weeks

  3. Insulin Resistance

    Time frame: Baseline, 12 weeks

    Oral Glucose Tolerance Test (2 hour AUC)

Other outcomes

  1. The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA)

    Time frame: Baseline, 12 weeks

  2. Mitochondrial Respiration Rate

    Time frame: Baseline, 12 weeks

    Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)

  3. Fatty Acid Oxidation

    Time frame: Baseline, 12 weeks

    Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Exercise And Colorectal Cancer Treatment (EXACT) Trial

Acronym: EXACT

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Jun 5, 2019
Registry last updated
Sep 22, 2025

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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