The Exercise And Colorectal Cancer Treatment Trial

NCT03975491 | Active Not Recruiting Results

• 2 other identifiers: PBRC 2019-009R00CA218603
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• The Percentage Change in High-sensitivity C-reactive Protein

  Baseline, 12 weeks

• The Percentage Change in Interleukin-6

  Baseline, 12 weeks

Secondary Outcomes (3)

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

  Baseline, 12 weeks

• The Change in Circulating Tumor Cells Per mL Whole Blood

  Baseline, 12 weeks

• Insulin Resistance

  Baseline, 12 weeks

Other Outcomes (3)

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

  Baseline, 12 weeks

• Mitochondrial Respiration Rate

  Baseline, 12 weeks

• Fatty Acid Oxidation

  Baseline, 12 weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Moderate-intensity aerobic exercise

Behavioral: Moderate-Intensity Aerobic Exercise

Control

SHAM COMPARATOR

Wait-list control

Behavioral: Wait-List Control

Interventions

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.

Aerobic Exercise

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

• Compton SLE, Yang S, Maniscalco LS, Muhsen RA, Shrestha P, Wu X, Woodard KT, Zunica ERM, Cho E, Wall RL, Brown J, Jayaraman A, Kirby BJ, Gilmore LA, Greenway FL, Spielmann G, Brown JC. A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results. Contemp Clin Trials. 2024 Nov;146:107702. doi: 10.1016/j.cct.2024.107702. Epub 2024 Oct 1.

  PMID: 39362405 BACKGROUND

• Cho E, Chodzko M, Compton SLE, Yang S, Heymsfield S, Spielmann G, Brown JC. Effects of aerobic exercise on body composition and exerkines in colorectal cancer survivors. Front Sports Act Living. 2025 Jun 26;7:1579221. doi: 10.3389/fspor.2025.1579221. eCollection 2025.

  PMID: 40642656 BACKGROUND

• Brown JC, Compton SLE, Kang A, Jayaraman A, Gilmore LA, Kirby BJ, Greenway FL, Yang S, Spielmann G. Effects of exercise on inflammation, circulating tumor cells, and circulating tumor DNA in colorectal cancer. J Sport Health Sci. 2025 Dec;14:101036. doi: 10.1016/j.jshs.2025.101036. Epub 2025 Mar 17.

  PMID: 40107449 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

Results of other endpoints not submitted on July 25, 2025, will be reported at a later date.

Results Point of Contact

• Title: Dr. Justin Brown
• Organization: Pennington Biomedical Research Center

Justin.Brown@pbrc.edu

2257632715

Study Officials

• Justin C Brown, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 5, 2019
• Study Start: August 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: January 1, 2026
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After reporting and publication of the primary, secondary, and exploratory study outcomes is complete.
• Access Criteria: Data will be shared according to the principles outlined by Tudur Smith et al in BMC Medicine 2015.

Locations

US (1)