Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441773
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Impact of Respiratory Rehabilitation on Quality of Life in Patients with Metastatic Non-small Cell Lung Cancer Treated with Immunotherapy and Chemotherapy in the Maintenance Phase
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Impact of Respiratory Rehabilitation on Quality of Life in Patients with Metastatic Non-small Cell Lung Cancer Treated with Immunotherapy and Chemotherapy in the Maintenance Phase
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:
REHABIM
Brief Summary:
Lung cancer is highly prevalent with approximately 46363 new cases in 2018 accounting for 206 of cancer deaths in France At diagnosis 70 of patients have advanced or metastatic cancer treatable only by palliative care Respiratory rehabilitation aims to reduce symptoms enhance performance increase autonomy and improve patientsamp39 quality of life While effective for COPD patients and other conditions causing dyspnea its benefits in advanced non-operable lung cancer are less studied Some studies have shown the feasibility and safety of respiratory rehabilitation but few have compared its impact on non-operable lung cancer patients or assessed its effect on quality of life The main objective of the proposed study is to evaluate the impact of a respiratory rehabilitation program on the quality of life of patients with non-small cell lung cancer NSCLC undergoing maintenance chemotherapy and immunotherapy compared to a control group receiving standard care
Detailed Description:
Lung cancer accounts for an estimated 46363 new cases in 2018 At the time of diagnosis 70 of patients have locally advanced or metastatic cancer that can no longer be treated by surgery but only by palliative therapy It is the 4th most common cancer in France and the most common worldwide Lung cancer accounts for 206 of all cancer deaths in France
Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology and to enhance performance increase autonomy and promote activities of daily living It also aims to improve health-related quality of life and long-term maintenance of behavioral changes It has been shown to be effective for COPD patients Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea such as interstitial lung disease and pulmonary hypertension In the case of operable lung cancers numerous studies have focused on the preoperative and postoperative benefits
Very few studies have focused on its benefits in advanced non-operable lung cancer
The team of Olivier et al studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy Their study shows feasibility and safety for patients who complete the program but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed
The team of Edbrooke et al in 2019 is studying the value of a home-based rehabilitation program The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care a randomized controlled superiority trial The study showed no statistically significant difference at 9 weeks on the primary endpoint the 6-min walk test due to a lack of power in the trial A final study Park et al showed the feasibility of outpatient rehabilitation in twelve patients but did not conclude on the value of respiratory rehabilitation
Thus while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer and no study has assessed the impact of respiratory rehabilitation on quality of life as a primary endpoint although this would appear to be an essential element in the care of these patients
The main objective of our study is to evaluate the impact of a respiratory rehabilitation program rehabilitation group in patients with non-small cell lung cancer NSCLC treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase control group on quality of life at 2 months 8 weeks
Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology and to enhance performance increase autonomy and promote activities of daily living It also aims to improve health-related quality of life and long-term maintenance of behavioral changes It has been shown to be effective for COPD patients Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea such as interstitial lung disease and pulmonary hypertension In the case of operable lung cancers numerous studies have focused on the preoperative and postoperative benefits
Very few studies have focused on its benefits in advanced non-operable lung cancer
The team of Olivier et al studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy Their study shows feasibility and safety for patients who complete the program but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed
The team of Edbrooke et al in 2019 is studying the value of a home-based rehabilitation program The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care a randomized controlled superiority trial The study showed no statistically significant difference at 9 weeks on the primary endpoint the 6-min walk test due to a lack of power in the trial A final study Park et al showed the feasibility of outpatient rehabilitation in twelve patients but did not conclude on the value of respiratory rehabilitation
Thus while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer and no study has assessed the impact of respiratory rehabilitation on quality of life as a primary endpoint although this would appear to be an essential element in the care of these patients
The main objective of our study is to evaluate the impact of a respiratory rehabilitation program rehabilitation group in patients with non-small cell lung cancer NSCLC treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase control group on quality of life at 2 months 8 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02162-43 | REGISTRY | IDRCB | None |