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| ID | Type | Description | Link |
|---|---|---|---|
| R00CA218603 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | Moderate-intensity aerobic exercise |
|
| Control | Sham Comparator | Wait-list control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage Change in High-sensitivity C-reactive Protein | Baseline, 12 weeks | |
| The Percentage Change in Interleukin-6 | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage Change in 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin C Brown, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39362405 | Background | 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. | |
| 40642656 | 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. |
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Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
After reporting and publication of the primary, secondary, and exploratory study outcomes is complete.
Data will be shared according to the principles outlined by Tudur Smith et al in BMC Medicine 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Aerobic Exercise |
| FG001 | Control | Waitlist Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Aerobic Exercise |
| BG001 | Control | Waitlist Control |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage Change in High-sensitivity C-reactive Protein | Posted | Mean | 95% Confidence Interval | % change | Baseline, 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Aerobic Exercise | 0 |
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Results of other endpoints not submitted on July 25, 2025, will be reported at a later date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justin Brown | Pennington Biomedical Research Center | 2257632715 | Justin.Brown@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | Jul 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| 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. |
|
| Insulin Resistance |
Oral Glucose Tolerance Test (2 hour AUC) |
| Baseline, 12 weeks |
| Baseline, 12 weeks |
| Fatty Acid Oxidation | Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min) | Baseline, 12 weeks |
| 40107449 | Result | 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. |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| High Sensitivity C-Reactive Protein | Geometric Mean | Standard Deviation | mg/L |
|
| Interleukin-6 | Geometric Mean | Standard Deviation | pg/mL |
|
| Soluble Tumor Necrosis Factor-Alpha Receptor Two | Geometric Mean | Standard Deviation | pg/mL |
|
| Circulating Tumor Cells | Mean | Standard Deviation | cells/mL |
|
| Tumor Fraction | Mean | Standard Deviation | % cells of tumor origin (of all cfDNA) |
|
|
|
| Primary | The Percentage Change in Interleukin-6 | Posted | Mean | 95% Confidence Interval | % change | Baseline, 12 weeks |
|
|
|
|
| Secondary | The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two | Posted | Mean | 95% Confidence Interval | % change | Baseline, 12 weeks |
|
|
|
|
| Secondary | The Change in Circulating Tumor Cells Per mL Whole Blood | Posted | Mean | 95% Confidence Interval | cells/mL | Baseline, 12 weeks |
|
|
|
|
| Secondary | Insulin Resistance | Oral Glucose Tolerance Test (2 hour AUC) | Not Posted | Jan 2026 | Baseline, 12 weeks | Participants |
| Other Pre-specified | The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA) | Posted | Mean | 95% Confidence Interval | % change | Baseline, 12 weeks |
|
|
|
|
| Other Pre-specified | Mitochondrial Respiration Rate | Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells) | Not Posted | Jan 2026 | Baseline, 12 weeks | Participants |
| Other Pre-specified | Fatty Acid Oxidation | Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min) | Not Posted | Jan 2026 | Baseline, 12 weeks | Participants |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Control | Waitlist Control | 1 | 29 | 0 | 29 | 0 | 29 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |