Aerobic Exercise During Chemotherapy for Colorectal Cancer

(ACTION Trial)

Recruiting at 3 trial locations

Overseen By Justin C. Brown, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth Translational Research Institute

Disqualifiers: Metastatic cancer, Other active cancer, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

219 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying amounts of aerobic exercise might affect chemotherapy effectiveness in people with colon cancer. Participants will either engage in aerobic workouts ranging from 75 to 300 minutes a week or perform static stretching. The goal is to determine if exercise can help patients better tolerate chemotherapy. This trial may suit those who have undergone surgery for stage II or III colon cancer, plan to start chemotherapy, and currently engage in less than 60 minutes of structured aerobic exercise per week. As an unphased trial, this study offers a unique opportunity to contribute to understanding how lifestyle changes can improve cancer treatment outcomes.

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 the trial coordinators or your healthcare provider.

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

Research shows that aerobic exercise is generally safe and beneficial for colon cancer survivors. Studies have found that physical activity, such as aerobic exercise, can reduce the risk of cancer recurrence and extend life expectancy. For example, one study found that patients who exercised had a 28% lower chance of cancer returning compared to those who did not exercise.

Aerobic exercise can also enhance quality of life by reducing cancer-related fatigue, which is extreme tiredness. While researchers continue to determine the best type, intensity, and timing of exercise, evidence suggests that aerobic exercise is safe and beneficial for those with colon cancer. These studies have not reported any major negative effects related to aerobic exercise.

In summary, although more research is needed to identify the ideal exercise plan, current findings support the safety and benefits of aerobic exercise for colon cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about incorporating aerobic exercise during chemotherapy for colorectal cancer because it represents a non-drug approach that could enhance treatment outcomes. Unlike standard treatments like surgery, chemotherapy, and radiation, aerobic exercise offers a potential boost to patients' overall health and quality of life. The trial is exploring different exercise intensities, ranging from 75 to 300 minutes per week, to determine the optimal dose for benefits such as improved physical fitness, reduced fatigue, and better mental well-being. This approach could lead to a more holistic treatment strategy, making cancer care not just about fighting the disease, but also about strengthening the body.

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

Research shows that aerobic exercise can significantly benefit people undergoing treatment for colon cancer. Studies have found that regular aerobic activity improved the chances of staying cancer-free by 28% and increased overall survival by 37% for colon cancer patients. One study discovered that patients who joined a structured exercise program had a 90% chance of surviving for eight years, compared to 83% for those who only received health education. In this trial, researchers will assign participants to different arms with varying doses of aerobic exercise, ranging from 75 to 300 minutes per week, to evaluate its impact. Aerobic exercise is also linked to a better quality of life and more energy for colorectal cancer survivors. These findings suggest that aerobic exercise could powerfully support cancer treatment and improve outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeffrey A. Meyerhardt

Principal Investigator

Dana-Farber Cancer Institute

Justin C. Brown, Ph.D.

Principal Investigator

AdventHealth

Bette J. Caan, Dr.P.H.

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage II or III colon cancer who've had surgery to remove it and are about to start chemo. They should exercise less than an hour a week, be able to walk 400 meters, understand English, and be ready to exercise as per a questionnaire.

Inclusion Criteria

I am starting treatment with oxaliplatin-based chemotherapy.

I do not have any major surgeries planned during the study.

Engage in <60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise

Exclusion Criteria

Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

My colon cancer has spread to other parts of my body.

Concurrently actively treated other (non-colon) cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Exercise

Participants undergo chemotherapy with varying doses of aerobic exercise or attention control

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• Progressive stretching

Trial Overview

The study measures how different amounts of aerobic exercise affect the body's response to chemotherapy in colon cancer survivors compared to those doing just stretching exercises.

How Is the Trial Designed?

Group I: 75 min/wk aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise at a dose of 75 minutes per week

Group II: 300 min/wk aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise at a dose of 300 minutes per week

Group III: 225 min/wk aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise at a dose of 225 minutes per week

Group IV: 150 min/wk aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise at a dose of 150 minutes per week

Group V: Attention control Placebo Group 1 Intervention

Static stretching

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

A study involving 18 rectal cancer patients showed that a moderate-intensity aerobic exercise program during and after neoadjuvant chemoradiotherapy (NACRT) is both feasible and safe, with no serious adverse events reported.

Patients demonstrated high adherence to the exercise program, attending 83% of supervised sessions and averaging 222 minutes of unsupervised exercise per week, indicating that exercise can be integrated into their treatment regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I Study Examining the Feasibility and Safety of an Aerobic Exercise Intervention in Patients With Rectal Cancer During and After Neoadjuvant Chemoradiotherapy. Morielli, AR., Usmani, N., Boulé, NG., et al.[2017]

Aerobic exercise training (AET) combined with neoadjuvant chemotherapy (doxorubicin-cyclophosphamide) significantly improved exercise capacity and vascular function in 20 women with early breast cancer, suggesting a beneficial interaction between AET and chemotherapy.

The AET group showed a notable 38% reduction in tumor blood flow, along with changes in circulating factors related to angiogenesis, indicating that AET may influence tumor biology during chemotherapy, although no differences were found in tumor tissue markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. Jones, LW., Fels, DR., West, M., et al.[2021]

High-intensity interval exercise (HIIE) significantly improves cardiorespiratory fitness (V˙o2peak) and reduces fat mass more effectively than moderate-intensity continuous exercise (MICE) in colorectal cancer survivors over an 8-week period.

Even after reducing the frequency of HIIE sessions, participants maintained their fitness gains and fat loss, indicating that HIIE can provide lasting benefits with less training compared to traditional exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. Devin, JL., Jenkins, DG., Sax, AT., 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]

Rectal cancer patients found aerobic exercise during neoadjuvant chemoradiotherapy (NACRT) to be more enjoyable and less difficult than expected, which may help improve participation in exercise programs.

The most common perceived benefits of exercise included improved cardiovascular endurance and quality of life, while fatigue and other side effects were noted as barriers, particularly during NACRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise motivation in rectal cancer patients during and after neoadjuvant chemoradiotherapy. Morielli, AR., Usmani, N., Boulé, NG., et al.[2018]

In a study involving 577 participants undergoing cancer treatment, exercise was found to be safe, with 20% of adverse events (AEs) reported by coaches and 28% by participants, mostly being minor musculoskeletal issues.

High-intensity exercise was associated with a higher likelihood of AEs compared to low-to-moderate exercise, but both forms of exercise are recommended for patients if there are no medical contraindications, as serious complications like lymphedema and PICC issues were low and not significantly different across exercise intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. Henriksson, A., Johansson, B., Radu, C., et al.[2021]

A systematic review of 33 trials involving 3257 patients found that aerobic exercise during chemotherapy is safe and can improve or maintain fitness levels, with moderate intensity exercise (50-80% maximum heart rate) being particularly effective.

Exercise was associated with improved quality of life and physical functioning, as well as a quicker return to work, although it did not significantly affect chemotherapy completion rates or survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety and efficacy of aerobic exercise during cytotoxic chemotherapy treatment. Cave, J., Paschalis, A., Huang, CY., et al.[2021]

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