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
Recruiting · NCT06441773 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Brest
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% 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 patients\' 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.
Who can take part
Inclusion criteria
- Histologically proven stage IV non-small cell lung cancer patient
- First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase
- Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab
- Squamous cell carcinoma patient: maintenance with pembrolizumab alone
- Age of at least 18 years
- Performance status of 0 or 1
- Estimated life expectancy \> 12 weeks
- No contraindications to respiratory rehabilitation
- Adequate organ function, demonstrated by laboratory results within the last 3 weeks, allowing maintenance treatment:
- Normal liver function: bilirubin \< 1.5 x ULN, ALT and AST \< 2.5 x ULN or \< 5 x ULN in the case of liver metastases.
- Renal function (creatinine clearance calculation of at least \> 45 mL/min).
- Hematological function: absolute neutrophil count \> 1.5 x 10\^9/L and/or platelets \> 100 x 10\^9/L, hemoglobin \> 8 g/dL.
- Informed consent to participate in the study must be signed
- Patient must be affiliated with or beneficiary of social security
Exclusion criteria
- Small cell lung cancer, mesothelioma, neuroendocrine lung cancer
- Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Unresolved toxicity from previous treatment of grade \> 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion)
- Bone metastases preventing respiratory rehabilitation
- Contraindication to respiratory rehabilitation
- Uncontrolled infection
- Pregnancy and breastfeeding
- Surgery within two months prior to inclusion that could interfere with respiratory rehabilitation
- Persons under legal protection (guardianship or curatorship) or deprived of liberty
Where it is running
3 locations listed.
- CHU Brest - Brest, France
- CH Morlaix - Morlaix, France
- CH Cornouaille - Quimper, France