Exercise for Cancer

(Immuno-Ex Trial)

Overseen By Laurence Poirier, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Beta-blockers

Disqualifiers: Orthopedic, cardiac, metabolic, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 4

Duration: 1 week

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it does exclude those using beta-blockers.

What data supports the effectiveness of the treatment Aerobic Exercise for cancer patients?

Research shows that aerobic exercise can help cancer patients by improving their physical function, reducing fatigue, and enhancing their quality of life. It is also considered safe and beneficial even during chemotherapy, helping patients maintain an active lifestyle. ^{1 2 3 4 5}

Is exercise safe for cancer patients?

Exercise interventions for cancer patients, including those undergoing treatment, are generally safe with few serious adverse events reported. Most common minor issues include muscle soreness and circulatory problems, but serious complications are rare. Safety measures like regular breaks and consultations with medical teams are often in place to minimize risks. ^{6 7 8 9 10}

How does aerobic exercise as a treatment for cancer differ from other treatments?

Aerobic exercise is unique because it helps cancer patients improve their physical function and quality of life by reducing fatigue and other side effects of cancer and its treatment. Unlike traditional cancer treatments, which focus on directly targeting the cancer cells, aerobic exercise supports overall rehabilitation and can be safely integrated during and after cancer treatment to enhance recovery and well-being. ^{1 2 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to determine to what extent anticancer immune cells mobilized by aerobic exercise exhibit migratory and functional capacity towards cancer cells in patients undergoing treatment for breast or colorectal cancer. The main questions it aims to answer are: • Do anticancer immune cells mobilized by aerobic exercise will display migratory and functional capacity in patients undergoing treatment for curable breast or colorectal cancer? Hypothesis: exercise will promote cell migration and these cells will display anti-cancer functional characteristics, suggesting a possible adjuvant and immunotherapeutic use of exercise. • Do the magnitude of this anti-cancer immune response to exercise depend on the intensity of exercise? Hypothesis: the achievement of a higher intensity of effort will enable greater mobilization of the cytotoxic lymphocytes of interest, but also the expression of markers predicting a more interesting adjuvant potential to immunotherapy. Researchers will compare the effect of two exercise sessions, one moderate-intensity continuous exercise session (MOD) and one high-intensity interval exercise (HIIE) on the migration and anticancer potentials of mobilized immune cells. Individuals aged between 40 and 70 with curable colon or breast cancer will be recruited to carry out a cross-over study with two experimental conditions. After a preliminary assessment visit, they will take part in: * Two familiarization visits to validate the exercise prescription * Two experimental visits (HIIE and MOD). During these conditions, blood samples will be taken before, after and 1 hour after the end of exercise to collect immune cells in the blood. At the end of the visits, participants will leave with an accelerometer to wear for three days depending on conditions, and a notebook containing a questionnaire to assess fatigue levels over the same three days.

Research Team

Lee-Hwa Tai, PhD

Principal Investigator

University of Sherbrooke, Faculty of Medicine and Health Sciences, Department of Immunology and Cellular Biology

Eléonor Riesco, PhD

Principal Investigator

University of Sherbrooke, Faculty of Physical Activity Sciences, Department of Kinanthropology

Eligibility Criteria

This trial is for individuals aged 40-70 with curable breast or colorectal cancer. Participants will engage in two types of aerobic exercise to see if it helps their immune cells fight cancer better. They must be able to perform the exercises and follow the study's procedures, including wearing an accelerometer and completing a fatigue questionnaire.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Ability to perform moderate-intensity aerobic exercise (MOD) or EPI type cycling according to the established prescription without experiencing pain in connection with the bicycle saddle

I am between 40 and 70 years old.

Exclusion Criteria

Non-controlled health condition

I have a health condition that makes it unsafe for me to do aerobic exercise.

I am taking beta-blockers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Familiarization

Participants undergo two familiarization visits to validate the exercise prescription

1-2 weeks

2 visits (in-person)

Treatment

Participants complete two exercise sessions: one moderate-intensity continuous exercise session and one high-intensity interval exercise session. Blood samples are collected before, during, and after exercise.

1 week

2 visits (in-person)

Follow-up

Participants are monitored for changes in physical activity levels and cancer-related fatigue using an accelerometer and a questionnaire over three days.

3 days

Treatment Details

Interventions

• Aerobic Exercise

Trial Overview Researchers are testing whether moderate-intensity continuous exercise (MOD) or high-intensity interval exercise (HIIE) can boost the body's immune response against cancer in patients with breast or colorectal cancer. The study involves blood tests before, after, and one hour post-exercise to measure changes in anticancer immune cells.

Participant Groups

Group I: Condition HIIE Experimental Treatment 1 Intervention

Individuals undergoing cancer treatment will complete one session of high-intensity interval exercise (HIIE) with a ratio high-intensity/active recovery of 1 min /2 min. During the condition blood samples will be collected.

Group II: Condition MOD Active Control 1 Intervention

Individuals undergoing cancer treatment will complete one moderate-intensity continuous exercise (MOD) session during which blood samples will be collected. MOD will consist of aerobic exercise that match external workload of HIIE.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Findings from Research

Aerobic exercise is an effective additive treatment for cancer patients, helping to alleviate physical limitations and improve quality of life during and after oncological treatment.

Research indicates that aerobic exercise is feasible even for patients with advanced cancer, enabling them to recover physical function and return to a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aerobic endurance training for cancer patients]. Crevenna, R., Zielinski, C., Keilani, MY., et al.[2019]

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 6-week aerobic exercise program significantly improved physical performance in five cancer patients, increasing their maximum walking speed and distance, while also reducing fatigue levels.

The exercise regimen, which involved daily treadmill walking at a specific intensity, allowed all participants to resume normal daily activities without substantial limitations, highlighting its potential as a therapeutic intervention for cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise as therapy for cancer fatigue. Dimeo, F., Rumberger, BG., Keul, J.[2022]

Aerobic exercise therapy significantly improved quality of life (QoL) in women treated for breast cancer, with a notable mean difference of 9.8 units in the primary outcome measure compared to usual care after 8 weeks.

The benefits of aerobic exercise therapy extended to various aspects of well-being, including social/family and functional well-being, and were not observed in the exercise-placebo group, indicating that the improvements were specifically due to the aerobic exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of exercise therapy in women treated for breast cancer. Daley, AJ., Crank, H., Saxton, JM., et al.[2022]

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., 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]

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]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

A review by Cochrane researchers indicates that aerobic exercise is effective in reducing fatigue commonly experienced by cancer patients and those undergoing treatment.

This finding suggests that incorporating aerobic exercise into cancer care may improve the quality of life for patients dealing with fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise can help to alleviate the fatigue associated with cancer. [2019]

Aerobic exercise significantly improves shoulder joint range of motion (ROM) in breast cancer survivors, as shown by a meta-analysis of nine randomized controlled trials involving 421 patients.

However, the study found no significant improvement in upper limb muscle strength, indicating that while aerobic exercise benefits flexibility, it may not enhance strength in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic exercise on upper limb function following breast cancer treatment: a systematic review and meta-analysis. Yang, Y., Gu, D., Qian, Y., et al.[2021]

References

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[Aerobic endurance training for cancer patients]. [2019]

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

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Aerobic exercise as therapy for cancer fatigue. [2022]

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Randomized trial of exercise therapy in women treated for breast cancer. [2022]

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Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

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

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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]

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Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

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Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

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Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

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Exercise can help to alleviate the fatigue associated with cancer. [2019]

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Effectiveness of aerobic exercise on upper limb function following breast cancer treatment: a systematic review and meta-analysis. [2021]

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