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Clinical Trials in France / NCT06441773
Recruiting Not applicable

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

NCT06441773 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Brest
Phase
Not applicable
Started
2025-11-21
Last updated
2026-06-17

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Respiratory Rehabilitation

Respiratory Rehabilitation: An initial assessment is conducted upon admission to personalize the program. This includes: Clinical examination Spirometry Maximum Inspiratory Pressure (PImax) measurement Multidimensional Dyspnea Profile questionnaire at end of TM6 Exercise Functional Testing Measurement of quadriceps strength and endurance Blood gases Educational interview and shared educational assessment London Chest Activity of Daily Living (LCADL) Tobacco and/or dietary consultation The respiratory rehabilitation program, performed twice a week, includes: Exercise training on an ergocycle and treadmill (30 minutes at ventilatory threshold for the ergocycle; 30 minutes at 60-80% walking speed for the treadmill; or dyspnea rated 4-6 on the Borg scale after endurance exercise) Quadriceps muscle strengthening Therapeutic education program Group gymnastics Smoking cessation assistance Socio-psychological and nutritional support

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Quality of Life Measurement Using EORTC QLQ-C30 — Week 0
    The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
  • Quality of Life Measurement Using EORTC QLQ-LC13 — Week 0
    The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
  • Quality of Life Measurement Using EORTC QLQ-C30 — Week 8
    The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
  • Quality of Life Measurement Using EORTC QLQ-LC13 — Week 8
    The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks

Trial sites (3)

FacilityCityRegionStatus
CHU Brest Brest France Not Yet Recruiting
CH Morlaix Morlaix France Recruiting
CH Cornouaille Quimper France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06441773 on ClinicalTrials.gov ↗ ← All trials in France