216 Participants Needed

Exercise for Colorectal Cancer Side Effects

Recruiting at 7 trial locations
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Andrea Cercek, MD profile photo
Overseen ByAndrea Cercek, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different levels of treadmill walking can help manage side effects for people undergoing chemotherapy for colorectal cancer. Researchers aim to determine if aerobic exercise, such as walking, is practical, safe, and effective in improving the body's response to cancer treatment. Participants will be divided into groups walking for 90, 150, or 300 minutes per week. This trial is ideal for those diagnosed with colorectal cancer who currently exercise less than 90 minutes weekly and are willing to commit to a structured walking routine during treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to valuable insights.

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 is best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that walking on a treadmill, a type of aerobic exercise, is generally safe for people undergoing chemotherapy for colorectal cancer. Studies have found that this exercise does not increase the risk of side effects during treatment. In fact, extensive research supports the idea that exercise benefits people with colorectal cancer, even helping to lower the risk of the cancer returning or worsening.

This study tests different weekly walking durations—90, 150, and 300 minutes—to determine which amount is both safe and effective. Past research suggests that exercise not only is safe but also helps manage cancer treatment side effects. Participants in this study will have their exercise carefully monitored to ensure safety.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how structured treadmill walking can help manage side effects of colorectal cancer treatment. Unlike standard treatments, which often focus on medication and surgery, this approach uses individualized aerobic exercise tailored to each patient’s needs. Exercise therapy during chemotherapy could offer a non-invasive way to improve patient well-being, potentially reducing fatigue and enhancing recovery. By testing different exercise durations, the trial aims to identify the optimal "dose" of activity for maximum benefit, monitored through innovative technology like TeleEx.

What evidence suggests that this trial's exercise treatments could be effective for reducing colorectal cancer side effects?

Research shows that exercise, such as walking on a treadmill, can help manage side effects for people with colorectal cancer. This trial will evaluate different durations of structured treadmill walking, with participants assigned to one of three groups: 90 minutes per week, 150 minutes per week, or 300 minutes per week. One study found that participants in an exercise program had a 28% lower chance of cancer recurrence and a 37% lower risk of dying. Exercise is safe and can be done during and after cancer treatment. Those who exercise often feel better physically and cope with their treatments more effectively. Overall, exercise appears to be a promising way to improve quality of life and health outcomes for those with colorectal cancer.12567

Who Is on the Research Team?

Memorial Sloan Kettering Cancer Center

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with locally advanced rectal cancer who do less than 90 minutes of moderate to strenuous exercise weekly. They must be scheduled for TNT (total neoadjuvant therapy) and cleared for exercise. People can't join if they're in another study, have distant metastatic cancer, are treated for another invasive cancer, or have mental impairments.

Inclusion Criteria

Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
Willingness to comply with all study-related procedures
Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire
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Exclusion Criteria

Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
Receiving treatment for any other diagnosis of invasive cancer
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aerobic training (AT) during neoadjuvant chemotherapy, with individualized walking sessions up to 7 times per week.

Duration of chemotherapy treatment
Supervised sessions monitored using TeleEx

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of side effects and treatment adherence.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Structured Treadmill Walking
Trial Overview The study tests the effects of structured treadmill walking as a form of aerobic exercise on reducing side effects from colorectal cancer treatment. It aims to determine a safe and practical level of activity that improves treatment responses and reduces the need for additional medication.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: 90 min/wkExperimental Treatment1 Intervention
Group II: 300 mins/wkExperimental Treatment1 Intervention
Group III: 150 mins/wkExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

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.
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.
Acute high intensity interval exercise reduces colon cancer cell growth.Devin, JL., Hill, MM., Mourtzakis, M., et al.[2020]
A systematic review of five randomized controlled trials involving 238 colorectal cancer patients found that while exercise did not significantly improve quality of life or fatigue, it did lead to notable short-term improvements in physical fitness (SMD = 0.59).
Due to insufficient evidence regarding overall benefits and the absence of safety data, the study concluded that no recommendations can be made for routine exercise interventions in colorectal cancer patients.
A systematic review and meta-analysis of exercise interventions for colorectal cancer patients.Cramer, H., Lauche, R., Klose, P., et al.[2022]

Citations

Effect of exercise on colorectal cancer prevention and treatmentIn a meta-analysis study involving 21 studies, the association between physical activity and colon cancer did not differ with the anatomical location[14].
Exercise for Colorectal Cancer Side EffectsResearch shows that exercise, including aerobic activities like treadmill walking, can improve physical fitness and help manage treatment-related side effects ...
Effects of a Structured Exercise Program on Physical Activity ...Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial ...
Exercise and colorectal cancer: a systematic review ...Findings from this meta-analysis suggest that exercise is safe and feasible for individuals with colorectal cancer during and following ...
Clinical trial confirms exercise improves survival for colon ...The outcome: those who received the exercise program had a 28% lower risk of recurrence and new cancers and a 37% lower risk of death. “This is ...
Effects of exercise on inflammation, circulating tumor cells ...Physical activity (PA) after the diagnosis of colorectal cancer is associated with a 45% relative risk reduction in cancer recurrence and death., However, the ...
Exercise and colorectal cancer: prevention and molecular ...A huge number of clinical trials and meta-analysis have demonstrated that exercise is significantly effective in lowering the risk of colorectal cancer.
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