RecruitingNot ApplicableNCT06436625

Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy

Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy: a Randomized Controlled Trial (OPAL-study)


Sponsor

Karl Landsteiner Institute for Lung Research and Pneumological Oncology

Enrollment

70 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this prospective study is to evaluate the effects of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy. The main questions it aims to answer are: The primary objective of the study is to assess the effects of outpatient pulmonary rehabilitation (OPR) on exercise capacity measured by difference in the 6-minute walking test (6MWT) in patients with advanced stage lung cancer receiving immunotherapy measured by difference in the 6-minute walking test (6MWT). Secondary endpoints in this study include progression free survival (PFS) and the effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24). Researchers will compare two groups of patients: one group of patients receives 6 weeks of outpatient pulmonary rehabilitation (intervention group), while the other patient group serves as control since this is standard of care to evaluate the effects of outpatient pulmonary rehabilitation.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether outpatient pulmonary rehabilitation — structured exercise and breathing programs — can improve quality of life and physical fitness in patients with metastatic non-small cell lung cancer (NSCLC) who are receiving maintenance immunotherapy after their initial chemotherapy-immunotherapy treatment. **You may be eligible if...** - You are 18 or older with metastatic (Stage IV) or recurrent non-squamous NSCLC confirmed by biopsy or cell testing - You have not received prior immunotherapy for advanced disease (except your current first-line treatment) - Your cancer responded to or stabilized on four cycles of initial chemo-immunotherapy - You are now starting maintenance therapy - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have brain metastases causing symptoms - You have bone metastases at risk of fracturing with exercise - You have severe heart failure, unstable chest pain, or another serious condition that worsens with exercise - You had major surgery within 28 days prior Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERoutpatient pulmonary rehabilitation

Patients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).


Locations(1)

Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie

Vienna, Austria

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NCT06436625


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