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 | Not Yet Recruiting

• 2 other identifiers: 29BRC22.02552024-A02083-44
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer

Keywords

Respiratory rehabilitation

Outcome Measures

Primary Outcomes (4)

• Quality of Life Measurement Using EORTC QLQ-C30

  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

  Week 0

• Quality of Life Measurement Using EORTC QLQ-LC13

  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

  Week 0

• Quality of Life Measurement Using EORTC QLQ-C30

  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

  Week 8

• Quality of Life Measurement Using EORTC QLQ-LC13

  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

  Week 8

Secondary Outcomes (33)

• Evaluation of quality of life using multiple modalities of the QLQ-C30.

  Week 0

• Evaluation of quality of life using multiple modalities of the QLQ-C30.

  Week 8

• Evaluation of quality of life using multiple modalities of the QLQ-C30.

  Month 6

• Evaluation of quality of life using multiple modalities of the QLQ-C30.

  Month 12

• Evaluation of quality of life using multiple modalities of the QLQ-C13.

  Week 0

Study Arms (2)

Control

NO INTERVENTION

Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group)

Respiratory rehabilition

EXPERIMENTAL

Maintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions

Procedure: Respiratory Rehabilitation

Interventions

Respiratory Rehabilitation PROCEDURE

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

Respiratory rehabilition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Bone metastases preventing respiratory rehabilitation
• Contraindication to respiratory rehabilitation
• Uncontrolled infection
• Pregnancy and breastfeeding
• Persons under legal protection (guardianship or curatorship) or deprived of liberty

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

CHU Brest

Brest, 29609, France

Location

CH Morlaix

Morlaix, 29600, France

Location

CH Cornouaille

Quimper, 29107, France

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Florence Jacquemine Péguet-Ménard

CONTACT

06.23.25.64.50; jacquemine.menard@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-center, randomized, open-label, parallel-group, ratio-distributed (1:1) trial comparing the impact of respiratory rehabilitation (RR) on quality of life at 2 months in patients with advanced NSCLC associated with RR versus patients with advanced NSCLC without RR.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (3)