Exercise for Colorectal Cancer

(EXACT Trial)

Overseen By Erin LeJeune

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Metastatic cancer, Other active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how moderate-intensity aerobic exercise might help prevent the recurrence of colorectal cancer after treatment. Participants will either engage in regular exercise or be placed on a wait-list for comparison. The study seeks individuals who have completed surgery, chemotherapy, and, if needed, radiation for stage I-III colorectal cancer. Participants should be ready and able to start exercising and must not plan any major surgery during the study.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that moderate-intensity aerobic exercise is safe for colorectal cancer patients?

Research has shown that moderate-intensity aerobic exercise is generally safe for people with colorectal cancer. A review of studies found this type of exercise carries a low risk of serious side effects. One study revealed that individuals with colorectal cancer who followed a moderate exercise routine adhered to the plan without major issues.

Overall, moderate-intensity aerobic exercise appears safe and well-tolerated, making it a promising option for those seeking to prevent cancer recurrence after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about moderate-intensity aerobic exercise for colorectal cancer because it offers a non-invasive and side-effect-free approach to managing the disease. Unlike conventional treatments like surgery, chemotherapy, and radiation, which can have significant side effects, aerobic exercise may improve patients' health and quality of life without these drawbacks. Additionally, exercise can boost overall physical fitness, potentially enhancing the body's ability to recover and respond to other treatments. This approach is promising as it not only targets cancer-related symptoms but also supports overall well-being.

What evidence suggests that moderate-intensity aerobic exercise might be an effective treatment for preventing colorectal cancer recurrence?

Research has shown that moderate-intensity aerobic exercise, which participants in this trial may engage in, benefits individuals who have completed treatment for colorectal cancer. Studies indicate that regular physical activity can reduce the risk of colon cancer by up to 20%. Exercise also alleviates cancer-related fatigue, making daily tasks more manageable for survivors. Engaging in 150 minutes of this exercise weekly can lower inflammation markers, such as hs-CRP and IL6, which are crucial for overall health. Thus, exercise not only helps prevent cancer recurrence but also enhances the quality of life for survivors. Participants in the control arm will be placed on a wait-list, serving as a comparison group. ^{1 3 4 6 7}

Who Is on the Research Team?

Justin C Brown, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've finished treatment for stage I-III colorectal cancer and aren't very active, doing less than 90 minutes of moderate exercise a week. They can't be planning major surgery during the study or have other active cancers (except certain skin cancers), be in another weight loss or diet study, have metastatic colon cancer, weigh more than 181 kg, or have conditions that make exercising unsafe.

Inclusion Criteria

I have finished my chemotherapy treatments.

My colorectal cancer is confirmed and is at stage I, II, or III.

I have had surgery to remove a tumor.

Exclusion Criteria

Unable or unwilling to give informed consent

My current weight is 181 kg or more.

I am not willing or able to be assigned to a treatment by chance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 weeks of moderate-intensity aerobic exercise or are assigned to a wait-list control group

12 weeks

Regular exercise sessions

Follow-up

Participants are monitored for changes in systemic inflammation, insulin resistance, and other biological markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moderate-Intensity Aerobic Exercise
• Wait-List Control

Trial Overview The trial is testing if moderate-intensity aerobic exercise helps prevent colorectal cancer from coming back after treatment. Participants will either start an exercise program right away or be put on a wait-list while researchers track their health outcomes.

How Is the Trial Designed?

Group I: Aerobic Exercise Experimental Treatment 1 Intervention

Moderate-intensity aerobic exercise

Group II: Control Placebo Group 1 Intervention

Wait-list control

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Physical inactivity is linked to 13-14% of colon cancer cases, suggesting that being active may be more important than family history in reducing risk.

While there is some evidence that physical activity can improve outcomes after a colorectal cancer diagnosis, the specific effects of exercise interventions on cancer risk and prognosis remain unclear, and no optimal exercise regimen has been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. Harriss, DJ., Cable, NT., George, K., et al.[2021]

High-intensity exercise (HIE) significantly improved cardiorespiratory fitness (V̇O2peak) and body composition in colorectal cancer survivors over 4 weeks, showing increases in both absolute and relative V̇O2peak, while moderate-intensity exercise (MIE) did not yield similar benefits.

HIE led to increases in lean mass and decreases in fat mass and fat percentage, demonstrating its efficacy and safety as an intervention for improving health outcomes in colorectal cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. Devin, JL., Sax, AT., Hughes, GI., et al.[2022]

In the CAN-HOPE trial involving 69 colorectal cancer survivors, participants reported not meeting the minimum exercise guidelines in 39.2% of the weeks, highlighting significant challenges in adherence to exercise recommendations.

The most common barriers to exercise included lack of time, treatment side effects, and fatigue, which accounted for 70% to 80% of missed exercise weeks, suggesting targeted interventions could help improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. Courneya, KS., Friedenreich, CM., Quinney, HA., et al.[2022]

High-intensity interval exercise (HIIE) significantly improves cardiorespiratory fitness (V˙o2peak) and reduces fat mass more effectively than moderate-intensity continuous exercise (MICE) in colorectal cancer survivors over an 8-week period.

Even after reducing the frequency of HIIE sessions, participants maintained their fitness gains and fat loss, indicating that HIIE can provide lasting benefits with less training compared to traditional exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. Devin, JL., Jenkins, DG., Sax, AT., et al.[2022]

A study involving 18 rectal cancer patients showed that a moderate-intensity aerobic exercise program during and after neoadjuvant chemoradiotherapy (NACRT) is both feasible and safe, with no serious adverse events reported.

Patients demonstrated high adherence to the exercise program, attending 83% of supervised sessions and averaging 222 minutes of unsupervised exercise per week, indicating that exercise can be integrated into their treatment regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I Study Examining the Feasibility and Safety of an Aerobic Exercise Intervention in Patients With Rectal Cancer During and After Neoadjuvant Chemoradiotherapy. Morielli, AR., Usmani, N., Boulé, NG., et al.[2017]

In patients with non-metastatic colorectal cancer, tumor removal significantly improved their anaerobic threshold, indicating better aerobic performance post-surgery, although their lean muscle mass remained unchanged.

Self-reported physical activity levels decreased after tumor resection, suggesting that objective measures like cardiopulmonary exercise testing are more reliable for assessing recovery and performance capability than subjective reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical resection of primary tumour improves aerobic performance in colorectal cancer. Williams, JP., Nyasavajjala, SM., Phillips, BE., et al.[2014]

Acute high-intensity interval exercise (HIIE) significantly reduced colon cancer cell numbers immediately after exercise in a study involving 20 colorectal cancer survivors, suggesting that exercise may have a direct anti-cancer effect through transient changes in serum composition.

Following HIIE, there were notable increases in inflammatory cytokines like interleukin-6 and tumor necrosis factor-α, indicating that these cytokines may play a role in mediating the exercise's beneficial effects on colorectal cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute high intensity interval exercise reduces colon cancer cell growth. Devin, JL., Hill, MM., Mourtzakis, M., et al.[2020]

In a study of 321 colorectal cancer survivors, 57% were able to meet the recommended exercise guideline of over 150 minutes per week, highlighting the potential for regular physical activity in this population.

Key factors influencing exercise levels included personal beliefs about exercise, functional status, and environmental barriers like time constraints and weather, suggesting that tailored support from healthcare providers could enhance exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. Chou, YJ., Lai, YH., Lin, BR., et al.[2018]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228190/

Effect of different types of aerobic exercises on cancer ... Current research demonstrates that moderate-intensity exercise can effectively alleviate CRF [14]. Moreover, engaging in mixed-mode exercise, ...

2. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-01021-7

Exercise and colorectal cancer: a systematic review and meta ... This meta-analysis evaluated the safety, feasibility and effect of exercise among individuals with colorectal cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1521691823000215

What is the optimal type and dose of physical activity ... Epidemiological evidence shows that higher levels of physical activity reduce the relative risk of colon cancer by up to 20%. To design optimal physical ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1257767/full

The dose-response effect of aerobic exercise on ... Our results demonstrate that 24 weeks of 150 min/wk of moderate-intensity aerobic exercise reduce hs-CRP and IL6 by 35.4% and 29.6% among stage ...

5. link.springer.com link.springer.com/article/10.1007/s00520-025-09610-7

a systematic review and meta-analysis Compared to usual care, exercise training significantly improved in all CRF outcomes in colorectal, colon, and rectal cancer survivors (g = 0.28 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6522766/

Effect of exercise on colorectal cancer prevention and treatment In a meta-analysis study involving 21 studies, the association between physical activity and colon cancer did not differ with the anatomical location[14].

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002854

A randomized trial of aerobic exercise in colorectal cancer Colorectal cancer survivors achieved high adherence to a home-based moderate-intensity aerobic exercise prescription that improved fitness capacity and ...