Aerobic Exercise for Colorectal Cancer

(RESTORE Trial)

Recruiting at 1 trial location

Overseen By Justin C. Brown, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth Translational Research Institute

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of aerobic exercise on fat between muscles in colorectal cancer survivors. Participants will either engage in regular aerobic exercise or follow a stretching routine for comparison. The trial seeks individuals who have had stage I, II, or III colon or rectal cancer, completed treatment, and currently exercise less than 150 minutes a week. As an unphased trial, it offers a unique opportunity to contribute to understanding exercise benefits for 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 prior data suggests that aerobic exercise is safe for colorectal cancer survivors?

Research shows that aerobic exercise is generally safe and beneficial for people with colorectal cancer. Studies have found that exercise can reduce the risk of cancer returning and improve survival rates. For instance, one study found that 80.3% of patients who exercised were alive and cancer-free after five years, compared to 73.9% in a group that did not exercise.

Another study showed that structured exercise programs lowered the risk of cancer recurrence by 28%. While these studies highlight the benefits, they also indicate that participants tolerate aerobic exercise well, with no major reports of harmful side effects.

Overall, evidence supports aerobic exercise as a safe and helpful addition to cancer care. It not only improves treatment outcomes but also enhances the quality of life for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise as a treatment for colorectal cancer because it offers a non-invasive and low-cost option that complements traditional therapies like surgery, chemotherapy, and radiation. Unlike these standard treatments, aerobic exercise focuses on enhancing the body's natural health and potentially improving quality of life and overall fitness. The unique aspect of this approach is its ability to support the immune system and reduce inflammation, which can play a role in cancer progression. By aiming for 225 minutes of exercise per week, this regimen seeks to offer a holistic benefit without the side effects typically associated with conventional cancer treatments.

What evidence suggests that aerobic exercise could be effective for colorectal cancer survivors?

Research has shown that aerobic exercise, which participants in this trial may receive, can greatly benefit individuals who have had colorectal cancer. A review of several studies found that regular physical activity can reduce the risk of colon cancer by 24%. Additionally, exercise can improve survival rates and help individuals remain cancer-free longer. Specifically, 80.3% of patients who exercised regularly were alive and cancer-free after five years, compared to 73.9% of those who did not exercise. Overall, these findings suggest that aerobic exercise is a promising way to support better outcomes for colorectal cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Justin C. Brown, Ph.D.

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

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 have finished all my treatments for cancer.

Willing to be randomized

Ability to provide written informed consent

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

I am scheduled for additional cancer treatments after surgery.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

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

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 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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6522766/

Effect of exercise on colorectal cancer prevention and treatment A meta-analysis showed that physical activity resulted in a 24% decrease in colon cancer risk [risk ratio (RR): 0.76, 95% confidence interval (CI): 0.72–0.81][ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531371/

A Randomized Trial of Aerobic Exercise in Colorectal Cancer Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, ...

3. privatehealth.com privatehealth.com/new-study-shows-exercise-improves-survival-in-colon-cancer-patients/

New Study Shows Exercise Improves Survival in Colon ... – 80.3% of patients remained alive and cancer-free at 5 years follow-up in the exercise group, while in the control group, this value was 73.9%.

4. cancernetwork.com cancernetwork.com/view/new-colon-cancer-data-shows-importance-of-exercise-therapy-for-survival

New Colon Cancer Data Shows Importance of Exercise ... Exercise significantly enhances cancer treatment outcomes, improving survival rates and quality of life for patients with colon cancer who ...

5. ascopost.com ascopost.com/news/june-2025/structured-exercise-program-improves-survival-in-some-patients-with-colon-cancer/

Structured Exercise Program Improves Survival in Some ... Eight-year overall survival was 90% in the structured exercise program arm and 83% in health education materials arm (HR = 0.63; 95% CI = 0.43– ...

6. aicr.org aicr.org/resources/blog/new-study-shows-benefits-of-physical-activity-for-colon-cancer-survivors/

New Study Shows Benefits of Physical Activity for Colon ... Colon cancer survivors who took part in a three-year structured exercise program had a 28 percent lower risk of cancer recurrence or a second ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14532-y

Effect of different types of aerobic exercises on cancer-related ... Research indicates that aerobic exercises can alleviate CRF, but the optimal type, intensity, and timing of exercise interventions remain unclear.