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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.

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.

What data supports the effectiveness of the treatment Structured Treadmill Walking, Aerobic Exercise, Treadmill 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 in colorectal cancer patients. Exercise has been linked to better treatment completion rates and reduced toxicities, such as nausea and neurotoxicity, which are common side effects of cancer treatments. ^{1 2 3 4 5}

Is treadmill walking safe for humans?

Treadmill walking, as a form of aerobic exercise, has been studied in various groups, including overweight and obese women, and is generally considered safe. It can help improve cardiovascular health and energy expenditure without significant safety concerns. ^{6 7 8 9 10}

How does exercise differ from other treatments for colorectal cancer side effects?

Exercise is unique because it not only helps improve physical fitness and quality of life for colorectal cancer survivors, but it also potentially reduces cancer cell growth and recurrence risk through mechanisms like inflammatory pathways. Unlike traditional treatments, exercise offers a non-invasive way to manage side effects and improve overall health. ^{1 2 3 11 12}

Research Team

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

Willingness to comply with all study-related procedures

Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire

Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

Exclusion Criteria

Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

My cancer has spread to distant parts of my body.

Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes

Timeline

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

Treatment Details

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.

Participant Groups

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 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 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 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

A systematic review and meta-analysis of exercise interventions for colorectal cancer patients. [2022]

4. 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]

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

Exercise during adjuvant treatment for colorectal cancer: treatment completion, treatment-related toxicities, body composition, and serum level of adipokines. [2020]

6. Turkey 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The energetic and cardiovascular response to treadmill walking and cycle ergometer exercise in obese women. [2022]

8. United States 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? [2022]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Accumulating aerobic exercise for effective weight control. [2019]

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

Colorectal cancer survivorship: movement matters. [2021]

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

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