Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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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: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Brest
NOT_YET_RECRUITING
Brest
CH Morlaix
RECRUITING
Morlaix
CH Cornouaille
RECRUITING
Quimper
Contact Information
Primary
Florence Jacquemine Péguet-Ménard
jacquemine.menard@chu-brest.fr
06.23.25.64.50
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2028-11-21
Participants
Target number of participants: 96
Treatments
No_intervention: Control
Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group)
Experimental: Respiratory rehabilition
Maintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov