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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Moderate-Intensity Aerobic Exercise for colorectal cancer?

Research shows that moderate-intensity exercise can help improve cardiorespiratory fitness (how well the heart and lungs work) and body composition (balance of muscle and fat) in colorectal cancer survivors, which are important for better health outcomes. ^{1 2 3 4 5}

Is moderate-intensity aerobic exercise safe for people with colorectal cancer?

Exercise, including moderate-intensity aerobic exercise, is generally safe for people with colorectal cancer, as no adverse events related to exercise interventions were reported in the studies reviewed. ^{1 6 7 8 9}

How does moderate-intensity aerobic exercise differ from other treatments for colorectal cancer?

Moderate-intensity aerobic exercise is unique because it is a non-drug treatment that can improve cardiorespiratory fitness and body composition in colorectal cancer survivors, potentially reducing adverse effects from cancer treatment. Unlike traditional treatments, it may also influence cancer outcomes by temporarily reducing cancer cell growth and increasing inflammatory responses immediately after exercise. ^{1 2 9 10 11}

Research Team

Justin C Brown, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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.

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Surgical resection of primary tumour improves aerobic performance in colorectal cancer. [2014]

3. England pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. [2022]

4. United States 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. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Exercise and colorectal cancer: a systematic review and meta-analysis of exercise safety, feasibility and effectiveness. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Exercise on Physical Function and Psychological Well-being in Older Patients With Colorectal Cancer Receiving Chemotherapy-A Systematic Review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Acute high intensity interval exercise reduces colon cancer cell growth. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. [2018]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. [2021]