Exercise Training for Non-Small Cell Lung Cancer

Overseen By Dong-Woo Kang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Must be taking: Immunotherapy

Disqualifiers: Active exercise, Unstable medical conditions, Noncompliance, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise can boost the immune system and improve treatment outcomes for people with non-small cell lung cancer (NSCLC) undergoing immunotherapy. One group will engage in aerobic interval training, which involves bursts of intense exercise followed by recovery periods, while the other group receives a general healthy lifestyle guidebook. The researchers aim to determine if exercise can strengthen the body's immune response and enhance treatment effectiveness. This trial suits NSCLC patients who began immunotherapy in the past one to three months and are not already engaging in regular intense exercise. As an unphased trial, it offers patients a chance to contribute to groundbreaking research that could enhance cancer treatment outcomes.

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

The trial information does not specify if you need to stop your current medications. However, if you have medical conditions that are unstable or uncontrollable with high-risk medications for exercise, you may be excluded from participating.

What prior data suggests that exercise training is safe for patients with non-small cell lung cancer?

Studies have shown that exercise is generally safe for people with non-small cell lung cancer (NSCLC). Research indicates that supervised aerobic exercise, like the kind in this trial, is both safe and practical for patients. One study found that patients who engaged in aerobic exercise did not experience significant negative side effects. Another study discovered that high-intensity interval training improved lung cancer symptoms without major safety concerns.

Overall, evidence shows that patients with lung cancer tolerate exercise well. While exercise might cause some discomfort, it is generally considered safe and could even help improve lung function and symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise training can benefit patients with non-small cell lung cancer (NSCLC). Traditionally, NSCLC treatments focus on surgery, chemotherapy, and radiation. This trial is different as it investigates aerobic exercise as a supportive approach, which is not a standard treatment method for cancer. One unique aspect is the use of virtual home-based aerobic interval training sessions with a stationary bike, offering a new delivery method that is accessible and convenient for patients. By assessing the impact of physical activity on lung function and overall health, researchers hope to find out if exercise can enhance recovery and improve quality of life for cancer patients.

What evidence suggests that exercise training is effective for improving immune activity and treatment response in non-small cell lung cancer?

Research has shown that aerobic exercise can benefit people with advanced lung cancer. It can significantly reduce cancer-related fatigue, particularly in those aged 60 or younger. A review of 35 studies demonstrated that high-intensity interval training (HIIT), a type of aerobic exercise, improves physical health in cancer patients. HIIT also enhances lung function and alleviates symptoms in lung cancer patients. In this trial, participants in Arm I will complete virtual home-based aerobic interval training sessions. These findings suggest that exercise might boost immune activity and improve the response of non-small cell lung cancer patients to immunotherapy treatment. ^{4 5 6 7 8}

Who Is on the Research Team?

Dong-Woo Kang, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with non-small cell lung cancer (NSCLC) who are currently undergoing immunotherapy. Participants should be able to perform physical activities as the study involves exercise training aimed at improving immune function and treatment outcomes.

Inclusion Criteria

I plan to continue immunotherapy for at least 6 months.

I can understand and am willing to sign the consent form, or I have someone who can legally do it for me.

I started immunotherapy 1 to 3 months ago.

Exclusion Criteria

Having a high risk for noncompliance with study procedures

Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month

Having medical conditions clinically unstable or uncontrollable with medications that deem high-risk for exercise participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aerobic interval training and receive a healthy lifestyle guidebook. Blood samples and various tests are conducted.

24 weeks

Virtual sessions once a week during weeks 1-4, twice a week during weeks 5-8, and three times a week during weeks 9-24

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments every three months up to the completion of immunotherapy.

Every 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training

Trial Overview The BOOST Trial is testing whether aerobic interval training can enhance immune activity and improve responses to immunotherapy in NSCLC patients. The study includes physical performance tests, educational sessions, and health record reviews among other assessments.

How Is the Trial Designed?

Group I: Arm I (aerobic training sessions, equipment, guidebook) Experimental Treatment 10 Interventions

Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes QW during weeks 1-4, BIW during weeks 5-8, and TIW during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, HR monitor, BP monitor, SPO2 monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study.

Group II: Arm II (guidebook) Active Control 8 Interventions

Patients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11910083/

Effect of exercise for patients with advanced lung cancer ... Exercise significantly reduces cancer-related fatigue (CRF) in patients with advanced lung cancer, with particular benefit in those aged ≤60 years.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06374160

Exercise in Patients With Advanced Non-small Cell Lung ... However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1440244023004218

Clinical updates on the effects of high intensity interval ... Comprehensive meta-analysis of 35 trials (n = 1893 participants) using HIIT showed significant improvements across several physical outcomes in the cancer ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1029738/full

Functional and postoperative outcomes after high-intensity ... In conclusion, HIIT improved pulmonary function and reduced postoperative atelectasis in patients with lung cancer. However, the incidence of postoperative ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT337859

High intensity interval training safety and efficacy in ... Patients in the exercise group demonstrated a significant improvement at 12 weeks in the Lung Cancer Symptoms domain on 28 points (22.3 vs 19.8, p = 0.015) as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6407827/

Exercise Training in Patients With Non–Small Cell Lung ... This study has revealed that exercise training is beneficial for lung capacity. The patients in the exercise group displayed significant improvements in FEV1, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2095254624001777

Effect of exercise for patients with advanced lung cancer ... Meta-analysis revealed that exercise significantly improved CRF in patients with advanced lung cancer (standardized mean difference (SMD) = –0.33; 95% ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.23967

Safety and feasibility of aerobic training on cardiopulmonary ... This pilot study provided proof of principle that supervised aerobic training is safe and feasible for postsurgical nonsmall cell lung ...