Aerobic Exercise for Cancer

Recruiting at 11 trial locations

Overseen By Jessica Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antitumor therapy

Disqualifiers: Unstable angina, Uncontrolled heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to answer the following question: Will aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) change the biomarkers (signs of disease) found in the blood?

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on any form of antitumor therapy, except for certain allowed therapies like endocrine therapy and anti-HER2 antibodies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on any antitumor therapy, except for certain allowed treatments like endocrine therapy and anti-HER2 antibodies.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for cancer patients?

Research shows that aerobic exercise can help cancer patients by reducing physical limitations, improving quality of life, and helping them recover physical function. It is also considered safe and beneficial for patients undergoing cancer treatment, including those with advanced cancer. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for cancer patients?

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

Is aerobic exercise safe for cancer patients during treatment?

Research shows that aerobic exercise is generally safe for cancer patients, even during treatment. Some studies have reported a few adverse events (unwanted effects), but these are not common, and exercise can help improve quality of life and physical function. ^{3 6 7 8 9}

Is aerobic exercise safe for cancer patients during treatment?

Research shows that aerobic exercise is generally safe for cancer patients, even during treatment. While some adverse events (unwanted effects) have been reported, they are not common, and exercise can help improve quality of life and physical function. ^{3 6 7 8 9}

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 medical treatments, it focuses on enhancing physical and emotional well-being through regular physical activity. ^{3 10 11 12 13}

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 medical treatments, it focuses on enhancing physical activity and rehabilitation, making it a supportive therapy that can be used alongside other cancer treatments. ^{3 10 11 12 13}

Research Team

Lee Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults who have had or are having androgen deprivation therapy, breast cancer with stable disease or no evidence of disease, high risk of cardiovascular disease, stage III colorectal or breast cancer post-therapy, localized prostate cancer under active surveillance, Lynch syndrome without intense exercise habits. Exclusions include severe heart/lung conditions, mental impairment affecting cooperation, other conflicting trials.

Inclusion Criteria

My breast cancer has not worsened for 6 months and I'm not on chemotherapy.

I am at high risk for heart disease.

Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

Exclusion Criteria

You have a current health condition that could affect your ability to exercise.

I have a heart rhythm problem that affects my daily activities or blood pressure.

I have fluid in my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive structured exercise therapy for 24 weeks, consisting of individualized walking delivered up to 5 times weekly, monitored via telemedicine.

24 weeks

Home-based exercise monitored via telemedicine

Follow-up

Participants are monitored for changes in biomarkers and residual tumor burden after treatment

2 years

Treatment Details

Interventions

• Exercise

Trial Overview The study investigates if aerobic exercise like walking can alter blood biomarkers in patients with various cancers. Participants will engage in structured exercises and provide blood samples to track changes.

Participant Groups

Group I: post treatment patients with breast or colorectal cancer Experimental Treatment 3 Interventions

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Group II: patients with clonal hematopoiesis Experimental Treatment 2 Interventions

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Group III: men with localized prostate cancer undergoing active surveillance Experimental Treatment 3 Interventions

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Group IV: Individuals with Lynch Syndrome Experimental Treatment 3 Interventions

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Group V: Individuals enrolled on Early Drug Development (EDD) trials Experimental Treatment 1 Intervention

Participants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Findings from Research

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]

Exercise training is a safe and well-tolerated adjunct therapy for cancer patients, showing potential to reduce treatment-related side effects during and after adjuvant therapy.

Current evidence suggests that incorporating exercise into the care plan for cancer survivors may enhance their overall management, although further research is needed to fully understand its benefits across different stages of cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in the management of solid tumors. Jones, LW., Peppercom, J., Scott, JM., et al.[2021]

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]

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]

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

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]

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]

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 training was found to be safe for women with metastatic breast cancer, with only 3% of participants lost to follow-up, but the overall attendance rate was lower than the predefined feasibility target, indicating challenges in implementation.

Despite feasibility issues, 42% of patients who completed the aerobic training showed improvements in their peak oxygen consumption (VO2peak) and functional capacity, suggesting potential benefits for select individuals that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. Scott, JM., Iyengar, NM., Nilsen, TS., et al.[2023]

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]

A twelve-week martial arts program combining aerobic and strength exercises significantly improved upper limb function and aerobic performance in 53 women who had undergone breast cancer surgery.

Participants in the study group showed notable increases in muscle strength, aerobic capacity, and muscle mass percentage, along with a decrease in fat mass, indicating the program's efficacy in enhancing physical condition post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synchronized Pedaling with Martial Arts Improves Quality of Life of Women with Breast Cancer. Navarro-Sanz, A., Espejo-Reina, A., Cerezo-Guzman, MV., et al.[2018]

References

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

Aerobic exercise as therapy for cancer fatigue. [2022]

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

Exercise therapy in the management of solid tumors. [2021]

3. Austria pubmed.ncbi.nlm.nih.gov

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Exercise in cancer. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. 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]

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

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

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

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

10. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]

12. China pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

Synchronized Pedaling with Martial Arts Improves Quality of Life of Women with Breast Cancer. [2018]