Clinical trial NCT06441773: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Respiratory rehabilitation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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\&amp;#39; 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.

Detailed description: Lung cancer accounts for an estimated 46,363 new cases in 2018. At the time of diagnosis, 70% of patients have locally advanced or metastatic cancer that can no longer be treated by surgery, but only by palliative therapy. It is the 4th most common cancer in France, and the most common worldwide. Lung cancer accounts for 20.6% of all cancer deaths in France.

Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology, and to enhance performance, increase autonomy and promote activities of daily living. It also aims to improve health-related quality of life and long-term maintenance of behavioral changes. It has been shown to be effective for COPD patients. Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea, such as interstitial lung disease and pulmonary hypertension. In the case of operable lung cancers, numerous studies have focused on the preoperative and postoperative benefits.

Very few studies have focused on its benefits in advanced, non-operable lung cancer.

The team of Olivier et al. studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy. Their study shows feasibility and safety for patients who complete the program, but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed.

The team of Edbrooke et al., in 2019, is studying the value of a home-based rehabilitation program. The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care, a randomized controlled superiority trial. The study showed no statistically significant difference at 9 weeks on the primary endpoint (the 6-min walk test), due to a lack of power in the trial. A final study (Park et al.) showed the feasibility of outpatient rehabilitation in twelve patients, but did not conclude on the value of respiratory rehabilitation.

Thus, while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer, few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer, and no study has assessed the impact of respiratory rehabilitation on quality of life (as a primary endpoint), although this would appear to be an essential element in the care of these patients.

The main objective of our study is to evaluate the impact of a respiratory rehabilitation program (rehabilitation group) in patients with non-small cell lung cancer (NSCLC) treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase (control group), on quality of life at 2 months (8 weeks).

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

Primary outcomes:
measure: Quality of Life Measurement Using EORTC QLQ-C30
timeFrame: Week 0
measure: Quality of Life Measurement Using EORTC QLQ-LC13
timeFrame: Week 0
measure: Quality of Life Measurement Using EORTC QLQ-C30
timeFrame: Week 8
measure: Quality of Life Measurement Using EORTC QLQ-LC13
timeFrame: Week 8
Secondary outcomes:
measure: Evaluation of quality of life using multiple modalities of the QLQ-C30.
timeFrame: Week 0
measure: Evaluation of quality of life using multiple modalities of the QLQ-C30.
timeFrame: Week 8
measure: Evaluation of quality of life using multiple modalities of the QLQ-C30.
timeFrame: Month 6
measure: Evaluation of quality of life using multiple modalities of the QLQ-C30.
timeFrame: Month 12
measure: Evaluation of quality of life using multiple modalities of the QLQ-C13.
timeFrame: Week 0
measure: Evaluation of quality of life using multiple modalities of the QLQ-C13
timeFrame: Week 8
measure: Evaluation of quality of life using multiple modalities of the QLQ-C13
timeFrame: Month 6
measure: Evaluation of quality of life using multiple modalities of the QLQ-C13
timeFrame: Month 12
measure: Evaluation of quality of life using the global health score of the QLQ-C30
timeFrame: Month 6
measure: Evaluation of quality of life using the global health score of the QLQ-C30
timeFrame: Month 12
measure: Evaluation of the number of deceased and surviving patients throughout the study follow-up.
timeFrame: Week 8
measure: Evaluation of the number of deceased and surviving patients throughout the study follow-up.
timeFrame: Month 6
measure: Evaluation of the number of deceased and surviving patients throughout the study follow-up.
timeFrame: Month 12
measure: Study of tumor response evaluation
timeFrame: Week 8
measure: Study of tumor response evaluation
timeFrame: Month 6
measure: Study of tumor response evaluation
timeFrame: Month 12
measure: Evaluation of exercise capacity using 6-Minute Walk Test
timeFrame: Week 0
measure: Evaluation of exercise capacity using 6-Minute Walk Test
timeFrame: Week 8
measure: Evaluation of the number of events of interest
timeFrame: Week 8
measure: Evaluation of the number of events of interest
timeFrame: Month 6
measure: Evaluation of the number of events of interest
timeFrame: Month 12
measure: Evaluation of the number of hospitalizations
timeFrame: Week 8
measure: Evaluation of the number of hospitalizations
timeFrame: Month 6
measure: Evaluation of the number of hospitalizations
timeFrame: Month 12
measure: Evaluation of anxiety and depressive disorders
timeFrame: Week 0
measure: Evaluation of anxiety and depressive disorders
timeFrame: Week 8
measure: Evaluation of dyspnea with mMRC scale
timeFrame: Week 0
measure: Evaluation of dyspnea with mMRC scale
timeFrame: Week 8
measure: Evaluation of dyspnea with Dyspnea-12 questionnaire
timeFrame: Week 0
measure: Evaluation of dyspnea with Dyspnea-12 questionnaire
timeFrame: Week 8
measure: Evaluation of self-esteem with ISP-6 questionnaire
timeFrame: Week 0
measure: Evaluation of self-esteem with ISP-6 questionnaire
timeFrame: Week 8
Other outcomes:
Locations:
Study officials:
References: