Exercise for Lung Cancer

Recruiting at 2 trial locations

Overseen By Tarah Ballinger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Immunotherapy

Must not be taking: Chemotherapy

Disqualifiers: Advanced heart failure, advanced respiratory disease, others

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

Compensation: Varies

Number of Visits: 48

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special exercise program can help people with advanced lung cancer live longer, feel better, and improve their quality of life. Participants will either continue their usual care or join a guided exercise program, which includes cardio, resistance training, and stretching, all performed at home with virtual support. It suits those with advanced lung cancer who are stable on immunotherapy and ready to try a regular exercise routine at home. As an unphased trial, this study provides a unique opportunity to explore the potential benefits of exercise in enhancing quality of life for those with advanced lung cancer.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you must be on maintenance immunotherapy for at least one month and cannot be currently receiving chemotherapy.

What prior data suggests that this exercise intervention is safe for participants with advanced lung cancer?

Research shows that exercise is generally safe for people with advanced lung cancer. Studies have found that exercise can boost energy, reduce complications, and improve quality of life for those with lung cancer. While it may not lower the risk of death, it helps people feel better overall.

One study examined a similar exercise program and found it was both feasible and safe for participants, meaning they could follow the program without facing serious issues.

In short, exercise has been shown to be well-tolerated and can offer benefits without causing significant harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Intervention for lung cancer because it offers a non-pharmacological approach that complements traditional treatments like surgery, chemotherapy, and radiation. Unlike standard treatments that often focus on directly targeting cancer cells, this intervention enhances overall physical health through regular exercise, potentially improving quality of life and treatment outcomes. The program's unique delivery method involves virtual, personalized training sessions that can be accessed from home, making it convenient and adaptable for participants. By incorporating cardiovascular, resistance, and balance exercises, it addresses multiple aspects of health, potentially helping patients manage symptoms and maintain strength during cancer treatment.

What evidence suggests that this exercise intervention is effective for advanced lung cancer?

Research shows that exercise can help people with advanced lung cancer. Studies have found that regular exercise reduces cancer-related fatigue, helping patients feel less tired. It also improves quality of life by enhancing overall well-being. Exercise boosts cardiorespiratory fitness, which is how well the heart and lungs work during activity. Patients who engage in both aerobic and resistance exercises have reported finding everyday tasks easier. In this trial, participants in the exercise intervention arm will follow a structured exercise program, which might benefit lung cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Tarah J Ballinger, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced lung cancer (stage III or metastatic NSCLC) who are on maintenance immunotherapy. They must have internet and equipment for virtual exercise, be stable or responding to current therapy, and not already doing regular moderate/vigorous exercise. Excluded are those with severe heart/respiratory conditions, uncontrolled psychiatric disorders, or a history of fragile bones.

Inclusion Criteria

Participants must have internet access and equipment to participate in virtual exercise

My lung cancer is at stage III or has spread beyond.

I have been on immunotherapy for at least 1 month and will continue for 3 more months.

Exclusion Criteria

Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ

Unable to participate in the supervised home-based exercise program as determined by the MOVE program

I do not have severe heart or lung problems, uncontrolled mental health issues, or a history of easy bone fractures that would stop me from doing supervised exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised home-based exercise program three times weekly for 12 weeks

12 weeks

36 virtual sessions

Follow-up

Participants are monitored for changes in fatigue, cardiorespiratory fitness, physical function, muscle mass, and depression scores

12 weeks

Assessments at baseline, week 12, and week 24

Long-term follow-up

Participants are monitored for long-term outcomes and adherence to the exercise program

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview

The study tests how an at-home multimodal exercise program affects survival, function, and quality of life in patients with advanced lung cancer. Participants will engage in supervised exercises virtually while continuing their maintenance immunotherapy treatment.

How Is the Trial Designed?

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

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.

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and lung cancer survivorship. Jones, LW.[2015]

Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.

While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

Lung cancer survivors showed a preference for starting exercise programs during adjuvant treatment, especially those who had undergone lung surgery, indicating the importance of tailoring exercise timing to individual treatment experiences.

Exercise levels significantly declined after diagnosis, but engaging in exercise post-treatment was associated with improved quality of life and reduced fatigue, highlighting the potential benefits of exercise for recovery in lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise preferences, levels and quality of life in lung cancer survivors. Leach, HJ., Devonish, JA., Bebb, DG., et al.[2018]

Exercise interventions for lung cancer patients are both safe and effective, leading to improvements in physical fitness, muscle strength, and quality of life, as well as reductions in cancer-related fatigue and dyspnoea.

Prehabilitation, or exercising before treatment, has been shown to enhance recovery outcomes after surgery, highlighting the importance of individualized exercise plans throughout the cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for people with lung cancer. Edbrooke, L., Granger, CL., Denehy, L.[2020]

The study assessed the feasibility of an 8-week hospital-based exercise program for 25 patients with advanced non-small cell lung cancer, finding that while 80% started the program, only 44% completed all sessions.

Patients who completed the exercise program reported significant improvements in lung cancer symptoms without any decline in their functional capacity, suggesting that structured exercise can be beneficial for those who can adhere to it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured exercise program for patients with advanced non-small cell lung cancer. Temel, JS., Greer, JA., Goldberg, S., et al.[2021]

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 can significantly benefit lung cancer patients by improving strength, endurance, and emotional well-being, regardless of the stage of their illness.

A structured recovery fitness program that includes breathing exercises, stretching, aerobic activities, and strength training is recommended to support lung cancer survivors and address their diverse needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. Michaels, C.[2020]

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]

Exercise is safe for individuals with lung cancer, showing no significant difference in the risk of adverse events compared to usual care, based on a systematic review of 32 trials involving 2109 participants.

Engaging in exercise post-diagnosis leads to significant improvements in various health-related outcomes, including quality of life, strength, and mental health, supporting the integration of exercise into standard cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for Individuals With Lung Cancer: A Systematic Review and Meta-Analysis of Adverse Events, Feasibility, and Effectiveness. Singh, B., Spence, R., Steele, ML., et al.[2021]

Physical activity and exercise significantly improve various aspects of health in lung cancer patients, including fatigue, quality of life, and psychological well-being, and are associated with better survival outcomes.

Despite the benefits, many lung cancer patients remain insufficiently active due to physical and psychosocial barriers, highlighting the need for tailored exercise programs developed in collaboration with healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Exercise in Lung Cancer Care: Will Promises Be Fulfilled? Avancini, A., Sartori, G., Gkountakos, A., et al.[2021]

This study will evaluate a 12-week exercise program for 216 patients with advanced lung cancer, focusing on improving physical capacity and quality of life through supervised cardiovascular and strength training.

The primary outcome measured will be maximal oxygen uptake (VO₂peak), with secondary outcomes including muscle strength, functional capacity, lung capacity, and patient-reported anxiety and depression, aiming to provide evidence on the benefits of exercise in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. Quist, M., Langer, SW., Rørth, M., et al.[2021]

A quasi-experimental trial showed that high-intensity interval training combined with team empowerment education significantly improved dyspnea, exercise capacity, exercise self-efficacy, anxiety, and depression in lung cancer patients undergoing surgery.

The intervention was found to be safe and feasible, suggesting it can effectively manage perioperative symptoms, although it did not impact the duration of thoracic drainage or total hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative High-Intensity Interval Training Combined With Team Empowerment Education in Lung Cancer Patients With Surgery: A Quasi-experimental Trial. Lu, HB., Wang, YQ., Liu, X., et al.[2023]

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