NCT06441773Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 29 May 2024
- Start date
- 21 Nov 2025
- Primary completion date
- 21 May 2028
- Lead sponsor
- University Hospital, Brest
- Diseases
- Lung cancer
- NCT number
- NCT06441773
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 21 Nov 2025 to the primary completion date, 21 May 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Surgery within two months prior to inclusion that could interfere with respiratory rehabilitation
Other illness
- 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
- Uncontrolled infection
Other
- Bone metastases preventing respiratory rehabilitation
- Contraindication to respiratory rehabilitation
- Pregnancy and breastfeeding
- Persons under legal protection (guardianship or curatorship) or deprived of liberty
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Brest Coordinator of this site? Confirm its status | Brest | France | Not yet recruiting |
| CH Morlaix Coordinator of this site? Confirm its status | Morlaix | France | Recruiting |
| CH Cornouaille Coordinator of this site? Confirm its status | Quimper | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.