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

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy.

Research Team

Dong-Woo Kang, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+