Aerobic Exercise for Colorectal Cancer

(RESTORE Trial)

Overseen By Justin C. Brown, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Metastatic cancer, Pregnancy, Cardiovascular, 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

Duration: 12 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal 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 aerobic exercise as a treatment for colorectal cancer?

Research shows that aerobic exercise can improve physical fitness in colorectal cancer patients, and high-intensity exercise may reduce colon cancer cell growth temporarily. These findings suggest that exercise could be beneficial for managing colorectal cancer. ^{1 2 3 4 5}

Is aerobic exercise safe for colorectal cancer patients?

Aerobic exercise is considered safe and feasible for rectal cancer patients during and after treatment, such as chemoradiotherapy. ^{1 3 6 7 8}

How is aerobic exercise different from other treatments for colorectal cancer?

Aerobic exercise is unique because it is a physical activity that can improve cardiorespiratory fitness and body composition, potentially reducing cancer cell growth and improving survival rates, unlike traditional drug therapies that focus on chemical intervention. ^{1 3 8 9 10}

Research Team

Justin C. Brown, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for adults over 18 who've had stage I, II, or III colon or rectal cancer and finished their surgery and other treatments. They should exercise less than 150 minutes a week and not be planning any major surgeries during the study. Participants must be ready to start exercising, have a doctor's approval, agree to random assignment in the trial, and give written consent.

Inclusion Criteria

I am 18 years old or older.

I have finished all my treatments for cancer.

Willing to be randomized

Exclusion Criteria

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

Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

My colorectal cancer has spread or come back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic exercise or static stretching for 225 minutes per week

12 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 is looking at how regular aerobic exercise affects muscle changes in people who've survived colorectal cancer compared to those who just do stretching exercises. The main focus is on fat within muscles after completing cancer treatment.

Participant Groups

Group I: Aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise at a dose of 225 minutes per week

Group II: 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

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]

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]

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]

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 pilot study involving 59 colorectal cancer patients undergoing adjuvant chemotherapy showed that a 6-month supervised aerobic exercise program significantly improved cardiorespiratory fitness and reduced mental fatigue compared to usual care.

The intervention group reported better health outcomes, including reduced motivation and fatigue, highlighting the potential benefits of exercise during cancer treatment and suggesting the need for further research in larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised aerobic exercise on cardiorespiratory fitness and patient-reported health outcomes in colorectal cancer patients undergoing adjuvant chemotherapy-a pilot study. Zopf, EM., Schulz, H., Poeschko, J., et al.[2022]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., 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 40 mice with induced colorectal cancer, all exercise groups showed a higher frequency of mucosal ulceration compared to the sedentary group, indicating that exercise may exacerbate certain inflammatory symptoms despite its potential benefits.

While all groups developed preneoplastic lesions, the exercise groups had a significantly higher number of polyps in both the distal and proximal regions of the colon compared to sedentary mice, suggesting that exercise may influence polyp development in colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aerobic and resistance exercise on the progression of colorectal cancer in an animal model. Neves, MB., Silva Junior, UND., Gonçalves, AF., et al.[2023]

A systematic review of 13 studies involving 19,135 colorectal cancer patients found that exercise significantly improves overall survival (OS) after cancer treatment, with moderate activity increasing survival by 18% and high activity by 36%.

Exercise also positively impacted cancer-specific survival (CSS), suggesting that promoting physical activity among colorectal cancer patients could enhance their long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and colorectal cancer survival: an updated systematic review and meta-analysis. Choy, KT., Lam, K., Kong, JC.[2022]

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

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of supervised aerobic exercise on cardiorespiratory fitness and patient-reported health outcomes in colorectal cancer patients undergoing adjuvant chemotherapy-a pilot study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

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

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

9. Brazil pubmed.ncbi.nlm.nih.gov

The effect of aerobic and resistance exercise on the progression of colorectal cancer in an animal model. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Exercise and colorectal cancer survival: an updated systematic review and meta-analysis. [2022]