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

Cancer Clinical Trial

— REHABIM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441773
• Other study ID #: 29BRC22.0255
• Secondary ID: 2023-A02162-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Brest
• Contact: Florence Jacquemine Péguet-Ménard
• Phone: 06.23.25.64.50
• Email: jacquemine.menard[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Evaluation of quality of life using multiple modalities of the QLQ-C30.	Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.	Week 0
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C30.	Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.	Week 8
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C30.	Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.	Month 6
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C30.	Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.	Month 12
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C13.	Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.	Week 0
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C13	Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.	Week 8
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C13	Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.	Month 6
Secondary	Evaluation of quality of life using multiple modalities of the QLQ-C13	Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.	Month 12
Secondary	Evaluation of quality of life using the global health score of the QLQ-C30	Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year.	Month 6
Secondary	Evaluation of quality of life using the global health score of the QLQ-C30	Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year.	Month 12
Secondary	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Week 8
Secondary	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Month 6
Secondary	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Evaluation of the number of deceased and surviving patients throughout the study follow-up.	Month 12
Secondary	Study of tumor response evaluation	Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.	Week 8
Secondary	Study of tumor response evaluation	Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.	Month 6
Secondary	Study of tumor response evaluation	Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.	Month 12
Secondary	Evaluation of exercise capacity using 6-Minute Walk Test	Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group)	Week 0
Secondary	Evaluation of exercise capacity using 6-Minute Walk Test	Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group)	Week 8
Secondary	Evaluation of the number of events of interest	Evaluation of the number of events of interest	Week 8
Secondary	Evaluation of the number of events of interest	Evaluation of the number of events of interest	Month 6
Secondary	Evaluation of the number of events of interest	Evaluation of the number of events of interest	Month 12
Secondary	Evaluation of the number of hospitalizations	Number of hospitalizations other than for maintenance treatment	Week 8
Secondary	Evaluation of the number of hospitalizations	Number of hospitalizations other than for maintenance treatment	Month 6
Secondary	Evaluation of the number of hospitalizations	Number of hospitalizations other than for maintenance treatment	Month 12
Secondary	Evaluation of anxiety and depressive disorders	Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8	Week 0
Secondary	Evaluation of anxiety and depressive disorders	Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8	Week 8
Secondary	Evaluation of dyspnea with mMRC scale	Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks	Week 0
Secondary	Evaluation of dyspnea with mMRC scale	Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks	Week 8
Secondary	Evaluation of dyspnea with Dyspnea-12 questionnaire	Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks	Week 0
Secondary	Evaluation of dyspnea with Dyspnea-12 questionnaire	Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks	Week 8
Secondary	Evaluation of self-esteem with ISP-6 questionnaire	Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks	Week 0
Secondary	Evaluation of self-esteem with ISP-6 questionnaire	Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks	Week 8