Exercise for Colorectal Cancer

Overseen by Christina M Dieli-Conwright, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Unstable comorbidities, Excessive exercise, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. The names of the study groups involved in this study are: * Exercise * Waitlist Control

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 your doctor or the study team.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for colorectal cancer?

Research suggests that physical activity can improve the quality of life for colorectal cancer patients and may be linked to better outcomes. Additionally, high intensity interval exercise has been shown to temporarily reduce colon cancer cell growth, indicating a potential benefit of exercise in managing colorectal cancer. ^{1 2 3 4 5}

Is exercise safe for people with colorectal cancer?

Exercise is generally considered safe for people with colorectal cancer, and it may improve quality of life and health outcomes. Studies suggest that physical activity can help reduce the risk of cancer recurrence and improve cardiovascular fitness, although the specific effects can vary. ^{6 7 8 9 10}

How is exercise as a treatment for colorectal cancer different from other treatments?

Exercise is unique as a treatment for colorectal cancer because it focuses on improving quality of life, slowing functional decline, and reducing mortality through physical activity, rather than using medication or surgery. It is a non-invasive approach that can be integrated into a patient's lifestyle, offering benefits like increased flexibility and better recovery after surgery. ^{2 9 11 12 13}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals with early-stage or metastatic colorectal cancer who are currently undergoing chemotherapy. Participants should be willing to either engage in an exercise program or be placed on a waitlist as part of the control group.

Inclusion Criteria

Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week

My doctor says I can safely do exercise and tests.

I don't plan to have major surgery during the next 12 weeks, except for a port placement.

Exclusion Criteria

Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study

Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise

Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo chemotherapy and are assigned to either an exercise group or a waitlist control group. The exercise group completes exercise sessions 3 times weekly.

12 weeks

Baseline and post-intervention in-office visits

Follow-up

Participants are monitored for changes in microbiome activity and chemotherapy toxicity after the intervention

4 weeks

Treatment Details

Interventions

• Exercise (Behavioural Intervention)

Trial Overview The COURAGE Trial is testing whether an exercise program can influence gut microbiome activity, reduce side effects from chemotherapy, and improve treatment outcomes for young-onset colorectal cancer patients compared to those not exercising.

Participant Groups

Group I: Group A: Exercise Group Experimental Treatment 1 Intervention

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: * Baseline in-office visit. * Completion of exercise sessions 3x weekly. * Post-intervention in-office visit.

Group II: Group B: Waitlist Control Group Active Control 1 Intervention

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: * Baseline in-office visit. * Participants will be asked to maintain baseline exercise behavior and/or usual, daily activities. * Post-intervention in-office visit. Participants will be offered to participate in the exercise program upon the completion of post-intervention assessments.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University

Findings from Research

In a study of 4,800 colorectal cancer patients, it was found that women and those with higher fatigue levels consistently engaged in lower levels of moderate-to-vigorous physical activity (MVPA) over five years post-diagnosis.

At six months post-diagnosis, CRC patients had significantly lower MVPA levels compared to the general population, highlighting a critical period for intervention to improve physical activity among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to Five Years after Diagnosis. Smit, KC., Derksen, JWG., Stellato, RK., et al.[2023]

A systematic review of four studies on colorectal cancer patients undergoing physical exercise found no significant improvement in quality of life compared to control groups.

While three studies involved unsupervised aerobic exercises and one used semi-supervised exercises, only one study reported some positive effects on physical, emotional, and functional well-being, indicating that the overall evidence does not strongly support exercise as a means to enhance quality of life in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise and Quality of Life of Patients Diagnosed with Colorectal Cancer: Systematic Literature Review. da Silva Bezerra, KH., de Oliveira, MVL., do Nascimento, IJB., et al.[2021]

A home-based physical activity intervention for colorectal cancer survivors significantly increased physical activity levels and aerobic fitness over 12 months, particularly at the 3-month mark, compared to a control group.

The intervention also improved motivational readiness for physical activity at 3 months, although no significant differences were observed in fatigue, physical functioning, or quality of life between the groups over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based physical activity intervention for colorectal cancer survivors. Pinto, BM., Papandonatos, GD., Goldstein, MG., 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]

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]

A review of 19 cohort studies found that physically active males have a significantly reduced risk of colon cancer, with risk ratios of 0.79 for occupational activities and 0.78 for recreational activities.

For women, only recreational physical activities were associated with a protective effect against colon cancer (RR = 0.71), while no significant protection was observed for rectal cancer in either sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. Samad, AK., Taylor, RS., Marshall, T., et al.[2006]

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]

A 12-week supervised exercise program significantly improved cardiorespiratory fitness, muscle strength, and quality of life in colorectal cancer patients undergoing chemotherapy compared to usual care.

The exercise intervention led to better outcomes in physical activity levels and reduced pain and emotional distress, suggesting that incorporating exercise into treatment plans can enhance the overall well-being of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. Lin, KY., Shun, SC., Lai, YH., et al.[2022]

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]

Physical activity is beneficial for colorectal cancer survivors, as it can reduce the risk of colon cancer recurrence and improve overall quality of life and cardiovascular health, based on a review of existing data.

While the evidence for rectal cancer survivors is less strong, physical activity still shows positive effects on quality of life and health outcomes, potentially through mechanisms involving inflammation and insulin-like growth factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. Denlinger, CS., Engstrom, PF.[2021]

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]

Colorectal cancer mortality has decreased over the past 20 years, largely due to better screening and treatment options.

Incorporating physical activity into the management plan for colorectal cancer survivors is crucial, as it enhances quality of life, slows functional decline, and reduces overall mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical activity on survival in patients with colorectal cancer. DeTroye, A., Christner, M., Eganhouse, D., et al.[2018]

A six-month mixed exercise program significantly improved flexibility, lower limb strength, and aerobic capacity in patients recovering from colorectal cancer surgery, compared to a control group that did not exercise.

Patients in the exercise group also experienced a notable reduction in body fat and an increase in cell mass, highlighting the potential of exercise to enhance physical recovery after surgery for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial. Mascherini, G., Ringressi, MN., Castizo-Olier, J., et al.[2020]

References

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

Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to Five Years after Diagnosis. [2023]

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

Physical Exercise and Quality of Life of Patients Diagnosed with Colorectal Cancer: Systematic Literature Review. [2021]

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

Home-based physical activity intervention for colorectal cancer survivors. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. [2006]

7. 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]

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

Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. [2022]

9. 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]

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

Colorectal cancer survivorship: movement matters. [2021]

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

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

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

The effects of physical activity on survival in patients with colorectal cancer. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial. [2020]