Exercise Therapy for Cancer and COVID-19 Recovery

No longer recruiting at 9 trial locations

Overseen By Jessica Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Home oxygen, Other cancer, Metastatic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 30 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 30-week walking program, a form of aerobic exercise therapy, to determine its safety and manageability for cancer patients who have recovered from a COVID-19 hospital stay. Researchers aim to assess whether this exercise plan causes only mild side effects. It targets individuals who overcame cancer at least a year ago, were hospitalized with COVID-19, and exercise less than 90 minutes a week. Participants must have space for a treadmill at home and receive approval for exercise. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this innovative approach.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does allow for current endocrine therapy and maintenance therapy, so you may be able to continue those.

What prior data suggests that this exercise therapy is safe for cancer patients recovering from COVID-19?

Research shows that exercise is generally safe for people recovering from COVID-19. Those who exercise tend to have a lower risk of severe outcomes, such as hospitalization. This suggests exercise benefits health and safety.

For cancer patients, exercise also appears beneficial. A study with breast cancer patients found that those who exercised experienced better outcomes during chemotherapy. This indicates exercise might be helpful without causing serious harm.

Although specific data on aerobic exercise for this exact group of patients is lacking, exercise programs are typically safe and can improve outcomes for cancer survivors. These programs often adjust to each person's fitness level, enhancing safety.

Overall, evidence suggests that aerobic exercise is well-tolerated and has few serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise therapy for cancer and COVID-19 recovery because it offers a natural, non-pharmaceutical approach to rehabilitation. Unlike traditional treatments that often involve medications or invasive procedures, aerobic exercise focuses on enhancing physical fitness and overall health, which can be particularly beneficial for post-cancer and post-COVID patients. The therapy aims to improve lung function, boost immune response, and enhance quality of life, potentially reducing the long-term symptoms associated with these conditions. This approach aligns with growing evidence on the benefits of exercise in managing chronic illnesses and recovery, offering a holistic path to healing.

What evidence suggests that aerobic exercise therapy might be an effective treatment for cancer and COVID-19 recovery?

Research shows that aerobic exercise can greatly improve physical abilities in cancer patients. In this trial, participants hospitalized for COVID-19 and post-cancer treatment will engage in a 6-week aerobic exercise program. Previous studies have shown that such programs help cancer patients recovering from COVID-19 walk faster and farther. Exercise is important for cancer survivors, aiding recovery from cancer and its treatments. It also improves fitness in those who had COVID-19, enhancing their overall ability to exercise. This suggests that regular aerobic exercise could be helpful for recovery in similar situations. ^{3 4 6 7 8}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had cancer, are recovering from COVID-19, and do less than 90 minutes of exercise a week. They must have space for a treadmill at home and be cleared to exercise. Women able to have children must not be pregnant or planning pregnancy during the study.

Inclusion Criteria

I am a woman under 50, can become pregnant, and have a recent negative pregnancy test.

I am not pregnant nor planning to become pregnant during the study.

It's been 1-10 years since I finished my primary cancer treatment, but I may still be on hormone therapy.

Exclusion Criteria

You are currently receiving treatment for any other type of invasive cancer.

Enrollment onto any other interventional investigational study

Any other condition 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

Treatment

Participants undergo a 30-week aerobic exercise therapy program tailored to their fitness levels

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after the exercise therapy program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Therapy

Trial Overview The trial tests a 30-week walking program tailored to fitness levels in cancer patients recovering from COVID-19. It aims to see if this aerobic exercise therapy is safe and causes few or mild side effects.

How Is the Trial Designed?

Group I: Participants who were hospitalized for COVID-19 Experimental Treatment 1 Intervention

Participants will be post-cancer treatment patients who were hospitalized for COVID-19.

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 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]

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 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]

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 6-week aerobic exercise program significantly reduced cancer-related fatigue in patients with solid tumors after chemotherapy and/or radiotherapy, as indicated by a substantial decrease in the Brief Fatigue Inventory (BFI) score.

Participants in the aerobic exercise group also showed marked improvements in physical performance and quality of life, measured by the 6-minute walk test and the Functional Assessment of Cancer Therapy-General (FACT-G) score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aerobic Exercise on Cancer-related Fatigue. Patel, JG., Bhise, AR.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-covid-19-2-2021-07ee7

Exercise Therapy for Cancer and COVID-19 Recovery A 6-week aerobic exercise program significantly improved physical performance in five cancer patients, increasing their maximum walking speed and distance, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9069989/

Exercise oncology during and beyond the COVID-19 pandemic Exercise is a critical adjuvant therapy for cancer survivors and has been shown to improve cancer and treatment-related outcomes (e.g., patient-reported ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2095254625000432

Effects of aerobic or resistance exercise during ... Aerobic and resistance exercise concomitant to NACT seem to beneficially affect tumor shrinkage and pCR, reduce the need for ALND among patients with HR+ ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2021.2009565

Exercise for counteracting post-acute COVID-19 syndrome ... In patients with cancer, exercise significantly increases cardiorespiratory fitness, and consequently, the individual's exercise capacity [Citation9]. Moreover, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9784943/

Efficacy of Therapeutic Exercise in Reversing Decreased ... Overall, post-COVID-19 syndrome patients who followed a ThEx intervention showed improvements in strength, respiratory function, physical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04824443

NCT04824443 | Exercise Therapy in Cancer Patients Who ... The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003135/

Decentralized trial of tolerability-adapted exercise therapy ... Self-reported exercise is associated with lower risk of severe outcomes after SARS-CoV-2 infection including hospitalization and death (12, 13).

8. cancer.jmir.org cancer.jmir.org/2021/4/e33130/

Telerehabilitation's Safety, Feasibility, and Exercise Uptake in ... Telerehabilitation is safe, feasible, and improved outcomes for cancer survivors. Learnings from this study may inform the ongoing implementation of cancer ...