Aerobic Exercise During Chemotherapy for Colorectal Cancer

(ACTION Trial)

Recruiting at 2 trial locations

Overseen By Justin C. Brown, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

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

Trial Summary

What is the purpose of this trial?

To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

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.

What data supports the effectiveness of the treatment Aerobic Exercise during chemotherapy for colorectal cancer?

Research suggests that aerobic exercise can improve quality of life and prognosis after chemotherapy, and it may help maintain cardiorespiratory fitness and body composition in colorectal cancer survivors. ^{1 2 3 4 5}

Is aerobic exercise safe during chemotherapy for colorectal cancer?

Research suggests that aerobic exercise is generally safe for people undergoing chemotherapy, with few adverse events reported. Studies have shown that exercise can be safely integrated into cancer treatment, although the intensity and type of exercise should be tailored to individual fitness levels and medical conditions. ^{2 4 5 6 7}

How does aerobic exercise during chemotherapy for colorectal cancer differ from other treatments?

Aerobic exercise during chemotherapy is unique because it focuses on improving physical fitness and quality of life rather than directly targeting cancer cells. Unlike traditional drug treatments, it involves physical activity to potentially enhance the body's response to chemotherapy and mitigate its side effects. ^{1 2 5 7 8}

Research Team

Jeffrey A. Meyerhardt

Principal Investigator

Dana-Farber Cancer Institute

Justin C. Brown, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Bette J. Caan, Dr.P.H.

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of the safety and efficacy of aerobic exercise during cytotoxic chemotherapy treatment. [2021]

3. United States 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. [2017]

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

Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. [2022]

5. 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]

6. England 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. [2021]

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

Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Exercise motivation in rectal cancer patients during and after neoadjuvant chemoradiotherapy. [2018]