Exercise for Colorectal Cancer Side Effects

Recruiting at 7 trial locations

Overseen By Andrea Cercek, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other cancer, Metastatic malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of chemotherapy treatment

216 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

Who Is on the Research Team?

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

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

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?

Group I: 90 min/wk Experimental Treatment 1 Intervention

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.

Group II: 300 mins/wk Experimental Treatment 1 Intervention

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 3: 300 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.

Group III: 150 mins/wk Experimental Treatment 1 Intervention

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 2: 150 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of exercise interventions for colorectal cancer patients. Cramer, H., Lauche, R., Klose, P., et al.[2022]

Both walking with the Equipment for Clever Exercise (ECE PEDO) and supervised treadmill walking significantly improved abdominal obesity and increased VO2max in overweight and obese women after a 12-week program.

Walking with ECE PEDO specifically resulted in a greater reduction in visceral fat thickness compared to treadmill walking, highlighting its effectiveness as a novel exercise tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of moderate-intensity walking provided feedback by ECE PEDO on abdominal fat in overweight and obese women: A randomized, exercise study. Göçer, E., Ardıç, F., Akkaya, N., et al.[2022]

In a study comparing exercise responses in 15 obese women and 6 normal weight women, it was found that walking (treadmill) is more efficient for obese individuals, allowing them to achieve energy expenditure with lower heart rates compared to cycling.

While both exercise types showed higher metabolic rates in obese women, cycling did not impair muscle efficiency when accounting for body mass, but walking resulted in a higher net cost of transport, suggesting that biomechanics play a role in exercise choice for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The energetic and cardiovascular response to treadmill walking and cycle ergometer exercise in obese women. Lafortuna, CL., Agosti, F., Galli, R., et al.[2022]

In a study of 249 older adults with cardiovascular disease or metabolic syndrome, combining dietary weight loss with aerobic training (WL + AT) or resistance training (WL + RT) significantly improved health-related quality of life and satisfaction with physical function compared to dietary weight loss alone (WL).

Participants in the WL + AT group showed greater walking self-efficacy at 6 months and maintained higher scores at 18 months, while both WL + AT and WL + RT groups reported better stair climbing efficacy, highlighting the importance of incorporating exercise into weight loss programs for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in health-related quality of life and social cognitive outcomes in obese, older adults in a randomized controlled weight loss trial: Does physical activity behavior matter? Fanning, J., Walkup, MP., Ambrosius, WT., 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]

Patients with locally advanced colorectal cancer who engaged in exercise during adjuvant treatment had a fivefold lower chance of needing dose adjustments compared to those who did not exercise, indicating better tolerance to treatment.

The exercise group experienced significantly less severe nausea and neurotoxicity, and showed beneficial changes in body composition and serum levels of adiponectin, suggesting that exercise can improve both physical and biochemical responses during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during adjuvant treatment for colorectal cancer: treatment completion, treatment-related toxicities, body composition, and serum level of adipokines. Shim, YJ., Kim, HJ., Oh, SC., et al.[2020]

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]

Both short-bout (five times a week) and long-bout (twice a week) aerobic exercise programs were equally effective in reducing body weight, body fat percentage, and waist circumference in overweight Singaporean females over an eight-week period.

The study involved 30 participants and showed that moderate aerobic exercise can effectively help manage body composition without affecting lean body mass, regardless of the frequency of exercise sessions, as long as the total energy expenditure is consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accumulating aerobic exercise for effective weight control. Sykes, K., Choo, LL., Cotterrell, M.[2019]

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 meta-analysis of 21 studies involving 1129 women with overweight and obesity found that exclusive walking significantly improves total cholesterol and low-density lipoproteins (LDL), indicating its efficacy as a non-pharmacologic intervention.

The greatest improvements in cholesterol levels were observed in women with obesity, suggesting that walking can be particularly beneficial for this group in managing lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Exclusive Walking on Lipids and Lipoproteins in Women with Overweight and Obesity: A Systematic Review and Meta-Analysis. Ballard, AM., Davis, A., Wong, B., et al.[2022]

Citations

1.

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].

2.

withpower.com

withpower.com/trial/exercise-for-colorectal-cancer-side-effects-af018

Exercise for Colorectal Cancer Side Effects

Research shows that exercise, including aerobic activities like treadmill walking, can improve physical fitness and help manage treatment-related side effects ...

3.

aacrjournals.org

aacrjournals.org/cebp/article/25/6/969/282900/Effects-of-a-Structured-Exercise-Program-on

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7513291/

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 ...

5.

cancer.ca

cancer.ca/en/about-us/media-releases/2025/exercise-improves-survival-for-colon-cancer

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 ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2095254625000146

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 ...

7.

cancerci.biomedcentral.com

cancerci.biomedcentral.com/articles/10.1186/s12935-022-02670-3

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.