Colon CancerEXACTNCT03975491
The Exercise And Colorectal Cancer Treatment Trial
A study testing Moderate-Intensity Aerobic Exercise in people with Colon Cancer and Rectal Cancer, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Moderate-Intensity Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Moderate-Intensity Aerobic Exercise, Wait-List Control
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic ExerciseBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Moderate-intensity aerobic exercise Receives: Behavioral: Moderate-Intensity Aerobic Exercise |
| Control | Sham comparator | Wait-list control Receives: Behavioral: Wait-List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage Change in High-sensitivity C-reactive Protein
Measured: Baseline, 12 weeks
The Percentage Change in Interleukin-6
Measured: Baseline, 12 weeks
Secondary outcomes (3)
The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two
Measured: Baseline, 12 weeks
The Change in Circulating Tumor Cells Per mL Whole Blood
Measured: Baseline, 12 weeks
Insulin Resistance
Oral Glucose Tolerance Test (2 hour AUC)
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Aug 2019
- Primary completion1 May 2023
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Justin Brown, Pennington Biomedical Research Center
- Investigators
- Justin C Brown, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975491
- Sponsor's protocol ID
- PBRC 2019-009
- Other IDs
- R00CA218603
- Acronym
- EXACT
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2019
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
Publications
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.
PubMed 39362405Cho 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.
PubMed 40642656Brown 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.
PubMed 40107449
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise And Colorectal Cancer Treatment (EXACT) Trial
- ClinicalTrials.gov ID
- NCT03975491
- Acronym / sponsor ID
- EXACT / PBRC 2019-009
- Conditions
- Colon Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Moderate-Intensity Aerobic ExerciseModerate-intensity aerobic exercise |
| Control | Sham comparator | Behavioral: Wait-List ControlWait-list control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Histologically-confirmed stage I-III colorectal cancer
- Completed surgical resection
- Completed chemotherapy (if applicable)
- Completed radiotherapy (if applicable)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic ExerciseThe 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. | Behavioural | Aerobic Exercise |
| Wait-List ControlParticipants 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. | Behavioural | Control |
Primary outcome
The Percentage Change in High-sensitivity C-reactive Protein
Time frame: Baseline, 12 weeks
The Percentage Change in Interleukin-6
Time frame: Baseline, 12 weeks
3 secondary outcomes
The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two
Time frame: Baseline, 12 weeks
The Change in Circulating Tumor Cells Per mL Whole Blood
Time frame: Baseline, 12 weeks
Insulin Resistance
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39362405Compton 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.
- Background: PubMed 40642656Cho 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.
- Results publication: PubMed 40107449Brown 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.
- Individual participant dataSharing planned: Yes. Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin C Brown, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Aerobic Exercise in people with Colon Cancer and Rectal Cancer, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage Change in High-sensitivity C-reactive Protein (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975491, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.