Exercise Therapy for Cancer

No longer recruiting at 6 trial locations

Overseen By Lee Jones, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antitumor therapy

Disqualifiers: Distant metastases, Invasive cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether exercise therapy is safe and effective for individuals with certain solid tumor cancers who are preparing for surgery. Participants will follow a customized treadmill walking program from home, using a digital platform, up to five times a week. The trial aims to determine if this exercise routine is easy to follow and causes few or mild side effects. Eligible participants have a diagnosis of specific cancers, such as lung or breast cancer, are not currently exercising much, and have surgery planned in more than three weeks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative exercise therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be receiving any form of antitumor therapy to participate.

What prior data suggests that this exercise therapy is safe for cancer patients?

Research has shown that exercise therapy can be a safe option for cancer patients. Studies have found that physical activity often reduces the side effects of cancer treatments. It can also decrease fatigue and enhance patients' overall quality of life. Additionally, evidence suggests that exercise may lower the risk of cancer recurrence and reduce mortality rates for some cancers, such as breast and colorectal cancer. Most people tolerate exercise therapy well, and it is unlikely to cause harm when done correctly. However, as with any new treatment, participants should follow the program with guidance to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Exercise therapy for cancer is unique because it uses a patient-centric, decentralized approach to deliver treatment. Unlike traditional cancer treatments that might involve medication or invasive procedures, this therapy involves individualized treadmill walking sessions that patients can do at home. Delivered through a digital platform, it allows for remote monitoring and flexibility, making it easier for patients to integrate into their daily lives. Researchers are excited about this treatment because it emphasizes patient empowerment and accessibility, potentially improving both physical fitness and quality of life during cancer treatment.

What evidence suggests that exercise therapy might be an effective treatment for cancer?

Research has shown that exercise therapy, which participants in this trial will receive, can benefit people with cancer. One study found that individuals following a structured exercise program had an 80% chance of being disease-free after five years, compared to 74% for those who only received health education materials. Exercise also reduces side effects of cancer treatment, such as fatigue, and enhances overall quality of life. In animal studies, exercise improved the effectiveness of treatments like chemotherapy. These findings suggest that exercise therapy could be a valuable component of cancer care. ^{1 6 7 8 9}

Who Is on the Research Team?

Lee Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This clinical trial is for individuals with solid tumor cancers who are scheduled to undergo standard surgery. The study aims to evaluate the effectiveness and safety of exercise therapy prior to surgery.

Inclusion Criteria

Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey

I have a confirmed, operable cancer that has not been treated yet.

My surgery is scheduled at least 3 weeks from now and won't be delayed for exercise therapy.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I am currently undergoing treatment for cancer.

Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Therapy

Participants undergo individualized treadmill walking up to 5 times weekly to achieve a cumulative dose of 225 minutes per week, administered via a decentralized platform

3 weeks

Remote monitoring via DPEx platform

Follow-up

Participants are monitored for safety and effectiveness after exercise therapy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Therapy

Trial Overview

The intervention being studied is exercise therapy. Researchers want to see if it's an effective pre-surgery treatment for those with solid tumors, and they'll also check how practical it is by monitoring participants' adherence.

How Is the Trial Designed?

Group I: Exercise therapy Experimental Treatment 1 Intervention

Exercise therapy will comprise individualized treadmill walking delivered up to 5 times weekly (over a 7-day period) to achieve a weekly cumulative dose of 225 minutes per week. The minimum treatment period will be 3 weeks. Exercise therapy will be administered via a patient-centric, decentralized platform: Digital Platform for Exercise (DPEx). DPEx will permit all study procedures to be conducted remotely in patients' homes.

Exercise Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Exercise Therapy for:

• Improvement of cardiorespiratory fitness in men with low-risk prostate cancer on active surveillance
• Reduction of urinary obstruction/irritation and fear of recurrence in men with low-risk prostate cancer on active surveillance

Approved in European Union as Exercise Therapy for:

• General health and wellness
• Prevention of chronic diseases through physical activity

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

A study of 350 cancer patients receiving physical therapist-led exercise counseling showed significant reductions in global distress and fatigue, indicating that exercise counseling can effectively improve symptoms related to cancer treatment.

Patients reported notable improvements in overall health and well-being after counseling, suggesting that exercise may play a crucial role in enhancing quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapist-Led Exercise Assessment and Counseling in Integrative Cancer Care: Effects on Patient Self-reported Symptoms and Quality of Life. Lopez, G., Eddy, C., Liu, W., et al.[2023]

Exercise therapy (ET) combined with radiation therapy (RT) is safe and well-tolerated, with 83.9% of patients completing the trials, indicating high acceptability and feasibility among cancer patients.

Patients receiving ET showed statistically significant improvements in quality of life, fatigue, mood, and physical function, highlighting the potential benefits of incorporating exercise into cancer treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Therapy and Radiation Therapy for Cancer: A Systematic Review. Zaorsky, NG., Allenby, T., Lin, J., et al.[2021]

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

This clinical trial will assess the impact of a 2-month supervised exercise program on quality of life, fatigue, and functional capacity in 66 patients with stage IV cancer undergoing chemotherapy, aiming to provide evidence for effective exercise interventions in cancer care.

The study will measure various outcomes, including health-related quality of life and functional capacity, at multiple time points, allowing for a comprehensive evaluation of the exercise program's efficacy compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial. Sancho, A., Carrera, S., Arietaleanizbeascoa, M., et al.[2018]

Exercise training is a safe and feasible adjunct therapy for patients with operable lung cancer, both before and after surgery, helping to improve their ability to tolerate exercise and potentially enhancing their quality of life.

For patients with inoperable lung cancer, while more research is needed, preliminary evidence indicates that carefully prescribed exercise training could also be beneficial and should be considered in their overall treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy across the lung cancer continuum. Jones, LW., Eves, ND., Waner, E., et al.[2021]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

A study involving 112 prostate cancer patients undergoing androgen deprivation therapy showed that 85% were able to safely complete a maximal exercise test, indicating that structured exercise testing is feasible in this population.

The low incidence of positive stress tests (3.2%) and the similar cardiovascular responses to exercise compared to healthy individuals suggest that the risk of adverse events during exercise testing is low for cancer patients, making it a safe option for exercise prescription.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximal exercise testing of men with prostate cancer being treated with androgen deprivation therapy. Wall, BA., Galvão, DA., Fatehee, N., et al.[2014]

Individualized exercise interventions have been shown to significantly alleviate symptoms related to cancer treatment, such as fatigue and muscular weakness, thereby improving the quality of life for cancer survivors.

Structured and scientifically-based exercise programs, monitored by cancer exercise specialists, can enhance functional capacity and immune function, highlighting the importance of exercise as a complementary therapy in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model program: exercise intervention for cancer rehabilitation. Schneider, CM., Dennehy, CA., Roozeboom, M., et al.[2017]

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 is an effective therapeutic intervention for cancer patients, helping to reduce side effects from treatments and significantly improving their quality of life during and after treatment.

Engaging in exercise before, during, and after cancer treatments leads to numerous beneficial outcomes, making it a crucial part of care for both patients undergoing treatment and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Recommendations for Cancer-Related Fatigue, Cognitive Impairment, Sleep problems, Depression, Pain, Anxiety, and Physical Dysfunction: A Review. Mustian, KM., Sprod, LK., Janelsins, M., et al.[2021]

An interventional exercise program for cancer patients was designed to enhance self-confidence and improve quality of life, focusing on cardiovascular function, metabolism, muscular strength, endurance, and flexibility.

The program included both body and mind fitness components, which are crucial for balance and overall recovery after cancer therapy, highlighting the importance of physical activity in post-cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intervention Exercise Program for Cancer Patients with Breast Cancer]. Pokorná, A., Střeštíková, R.[2019]

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]

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]

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Exercise significantly enhanced the efficacy of chemotherapy and tamoxifen in seven of eight rodent models in either an additive, sensitizing, or synergistic ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0031940624004322

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A systematic review of 25 studies (n = 1188) found significant between- and within-group improvements with exercise in the following percentages of studies: ...

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Preclinical and observational studies suggest that exercise may improve cancer outcomes. However, definitive level 1 evidence is lacking.

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sciencedirect.com

sciencedirect.com/science/article/pii/S1040842824003457

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In colorectal cancer, strong and highly suggestive evidence supported the association of PA with lower all-cause mortality. In lung cancer, strong evidence ...

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