Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-17
Brief Title:
Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy
Sponsor:
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Organization:
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Study Overview
Official Title:
Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy a Randomized Controlled Trial OPAL-study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAL
Brief 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
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
Detailed Description:
The effect of an outpatient pulmonary rehabilitation program on the quality of life performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy will be investigated Comparable data on rehabilitation under ongoing immunotherapy are almost non-existent in a prospective setting
In addition all patients with metastatic lung cancer could benefit from the study results if the benefit of outpatient rehabilitation can be proven in this patient population
Patients will be randomized into two treatment arms and will be allocated due to randomization process Both arms will receive standard-of care oncologic therapy according to national and international guidelines In addition one arm will receive 6 weeks of a standardized OPR intervention group
Patients who were randomized into the intervention group will be referred to one of the rehabilitation centers Therme Wien Med or Klinik Pirawarth in Vienna regarding of patients choice The OPR is performed identical at both rehabilitation centers and according to Austrian guidelines consistency was reassured by both heads of institutes
Before the intervention T0-baseline week 0 patients will perform a 6-minute walking test 6MWT primary endpoint together with additional secondary objective measurements see section secondary endpoints or graphical overview A follow-up will be performed after completion of OPR T1 week 6 and every 9 weeks thereafter for the first 52 weeks T1 FUP-T2 FUP-T3 FUP-T4-T6 After 52 weeks FUP-T7 the intervals for follow-up visits is determined by the treating physician
The end of study is reached if patient shows tumor progression according to RECIST 11 criteria after FUP-T3 week 24 or - if patients has experienced tumor progression before FUP-T3 - after FUP-T3 week 24
In addition all patients with metastatic lung cancer could benefit from the study results if the benefit of outpatient rehabilitation can be proven in this patient population
Patients will be randomized into two treatment arms and will be allocated due to randomization process Both arms will receive standard-of care oncologic therapy according to national and international guidelines In addition one arm will receive 6 weeks of a standardized OPR intervention group
Patients who were randomized into the intervention group will be referred to one of the rehabilitation centers Therme Wien Med or Klinik Pirawarth in Vienna regarding of patients choice The OPR is performed identical at both rehabilitation centers and according to Austrian guidelines consistency was reassured by both heads of institutes
Before the intervention T0-baseline week 0 patients will perform a 6-minute walking test 6MWT primary endpoint together with additional secondary objective measurements see section secondary endpoints or graphical overview A follow-up will be performed after completion of OPR T1 week 6 and every 9 weeks thereafter for the first 52 weeks T1 FUP-T2 FUP-T3 FUP-T4-T6 After 52 weeks FUP-T7 the intervals for follow-up visits is determined by the treating physician
The end of study is reached if patient shows tumor progression according to RECIST 11 criteria after FUP-T3 week 24 or - if patients has experienced tumor progression before FUP-T3 - after FUP-T3 week 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None