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.
Capable and willing to give signed informed consent, which includes compliance with the requirements
Age ≥ 18 years at the time of screening
Histological or cytological confirmed non-squamous non-small cell lung cancer
Previously untreated patients with histologically or cytologically documented metastatic (Stage IV according to Version 9 on the IASLC Staging Manual in Thoracic oncology) or recurrent NSCLC
Physical or cognitive condition or symptoms that contraindicate execution of physical exercise or participation in a clinical exercise-based trial
Symptomatic brain metastases
Bone metastases with risk of pathological fracture with exercise training as assessed by treating physician
Contraindication for immunotherapy
Parallel
outpatient pulmonary rehabilitation
Other interventionPatients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).
Six Minute Walking Test
The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity and will be measured at baseline and 8 weeks afterwards.
Progression-free survival (PFS)
Progression-free survival is defined as the time from therapy until the date of progressive disease using RECIST 1.1 assessments, or date of death due to any cause, whichever occurs first.
Six Minute Walking Test (longterm)
Effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24)
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Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Lead sponsor
Klinik Pirawarth
Collaborator
Therme Wien Med
Collaborator
