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

Launched by UNIVERSITY HOSPITAL, BREST · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a program called respiratory rehabilitation can improve the quality of life for patients with advanced non-small cell lung cancer (NSCLC) who are receiving maintenance treatment with chemotherapy and immunotherapy. Respiratory rehabilitation focuses on helping patients breathe better, feel more energetic, and enhance their overall well-being. While this approach has been shown to help patients with other lung conditions, its effects on those with advanced lung cancer are not well understood. The trial will compare patients who participate in the rehabilitation program with those who receive standard care to see if there are any significant improvements in their quality of life.

To be eligible for this trial, participants must be adults aged 18 or older with stage IV non-small cell lung cancer who are currently in the maintenance phase of their treatment. They should have good overall health, with certain lab test results showing that their organs are functioning well. Patients with specific types of lung cancer, those with severe health issues, or those undergoing other treatments that interfere with rehabilitation will not be included. Participants can expect to be part of a program designed to help them manage their symptoms and possibly improve their daily lives during their cancer treatment.

Gender

ALL

Eligibility criteria

• 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