Exercise for Colorectal Cancer

Overseen By Christina M Dieli-Conwright, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Unstable comorbidities, Excessive exercise, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise (also known as physical activity, workout, or fitness training) affects the gut microbiome, chemotherapy side effects, and overall treatment outcomes for individuals undergoing chemotherapy for colorectal cancer. Participants will be divided into two groups: one will engage in regular exercise sessions, while the other will maintain their usual activity level and join the exercise program later. Individuals with early-stage or metastatic colorectal cancer, who are undergoing chemotherapy and currently exercise less than 90 minutes per week, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on exercise and cancer treatment.

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 prior data suggests that exercise is safe for individuals with colorectal cancer?

Research shows that exercise is generally safe for people with colorectal cancer. A review of studies found that exercise after a colorectal cancer diagnosis links to a low risk of negative side effects, indicating that most people handled the exercise well without serious issues.

One study found that colon cancer survivors who exercised regularly had a 28% lower chance of cancer recurrence. Additionally, those who followed a structured exercise program had a 37% lower risk of death. These findings suggest that exercise is not only safe but might also provide important health benefits for those with colorectal cancer.

Overall, exercise appears to be a well-tolerated and potentially beneficial activity for people with colorectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for colorectal cancer because it offers a non-invasive, drug-free approach that can complement existing therapies like surgery, chemotherapy, and radiation. Unlike traditional treatments that often have significant side effects, exercise may enhance patients' overall well-being and potentially improve treatment outcomes by boosting physical fitness and reducing fatigue. Additionally, exercise can be easily integrated into daily life, making it an accessible option for many patients seeking to enhance their quality of life during and after cancer treatment.

What evidence suggests that exercise is effective for colorectal cancer?

Research has shown that exercise might benefit people with colorectal cancer. One study found that physical activity reduced the risk of colon cancer by 24%. Another study demonstrated that exercising after surgery and chemotherapy lowered the chance of cancer recurrence or new cancer development. Over eight years, participants who exercised had better survival rates. Exercise also improved the quality of life for colorectal cancer survivors. This trial will compare an Exercise Group, where participants will complete exercise sessions three times weekly, with a Waitlist Control Group, who will maintain their usual activities. This evidence suggests that exercise could be helpful for those with colorectal cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

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.

How Is the Trial Designed?

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+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

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]

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]

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]

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]

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