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NOT YET RECRUITING
NCT07886359
NA

Effects of Supervised Aerobic Exercise on Biomarkers in Patients With nSCLC Receiving Immunotherapy

Sponsor: Izmir Bakircay University

View on ClinicalTrials.gov

Summary

Exercise is increasingly recognized as a supportive intervention in oncology and may influence systemic inflammation, immune regulation, physical function, and the tumor microenvironment among patients with non-small cell lung cancer. The EXIMPACT trial will investigate the effects of a supervised aerobic exercise program on immune system- and tumor microenvironment-related biomarkers in patients with NSCLC receiving active immunotherapy. Although immunotherapy has improved outcomes for patients with NSCLC, factors influencing treatment response and strategies to enhance treatment efficacy remain under investigation.

Official title: Investigation of the Effects of Supervised Aerobic Exercise Program on the Immune System and Tumor-Associated Biomarkers in Patients With Non-Small Cell Lung Cancer Receiving Immunotherapy: A Single-Blind, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2027-01-04

Completion Date

2029-06-15

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

OTHER

Exercise

A resistance-based aerobic exercise program using a stationary bike will be implemented twice a week for a total of 24 weeks. Each session will last a total of 40 minutes, consisting of a 5-minute warm-up, a 30-minute exercise period, and a 5-minute cool-down. The moderate-intensity range (60-75% of VO₂max) is defined as the optimal range that is both safe and conducive to physiological adaptation. Exercise intensity will initially be determined based on the estimated VO2max value calculated from each individual's 6-Minute Walk Test result. Based on the clinical value obtained, the initial exercise intensity will be set, and during exercise, heart rate reserve (Karvonen formula) and the Borg Perceived Exertion Scale (target range of 11-14) will be monitored together; if the intensity becomes intolerable, it will be reduced by 5%. If an immune-related adverse event occurs, the exercise will be temporarily suspended.