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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Quality of Life Measurement Using EORTC QLQ-C30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group)
Respiratory rehabilition
Maintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions
干预措施: Respiratory Rehabilitation (Procedure)
结局指标
主要结局
Quality of Life Measurement Using EORTC QLQ-C30
时间窗: 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
时间窗: 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-LC13
时间窗: 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
Quality of Life Measurement Using EORTC QLQ-C30
时间窗: 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
次要结局
- 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-C13(Week 8)
- Evaluation of quality of life using multiple modalities of the QLQ-C13(Month 6)
- Evaluation of quality of life using the global health score of the QLQ-C30(Month 6)
- Evaluation of the number of deceased and surviving patients throughout the study follow-up.(Week 8)
- Evaluation of the number of deceased and surviving patients throughout the study follow-up.(Month 6)
- Study of tumor response evaluation(Week 8)
- Study of tumor response evaluation(Month 6)
- Evaluation of exercise capacity using 6-Minute Walk Test(Week 0)
- Evaluation of the number of events of interest(Week 8)
- Evaluation of the number of events of interest(Month 6)
- Evaluation of the number of hospitalizations(Week 8)
- Evaluation of the number of hospitalizations(Month 6)
- Evaluation of anxiety and depressive disorders(Week 0)
- Evaluation of dyspnea with mMRC scale(Week 0)
- Evaluation of dyspnea with Dyspnea-12 questionnaire(Week 0)
- Evaluation of self-esteem with ISP-6 questionnaire(Week 0)
- Evaluation of tiredness with EORTC QLQ FA-12 questionnaire(Week 8)
- Evaluation of quality of life using multiple modalities of the QLQ-C30.(Month 12)
- Evaluation of quality of life using the global health score of the QLQ-C30(Month 12)
- Evaluation of quality of life using multiple modalities of the QLQ-C13(Month 12)
- Evaluation of quality of life using multiple modalities of the QLQ-C13.(Week 0)
- Evaluation of the number of deceased and surviving patients throughout the study follow-up.(Month 12)
- Evaluation of the number of events of interest(Month 12)
- Evaluation of self-esteem with ISP-6 questionnaire(Week 8)
- Study of tumor response evaluation(Month 12)
- Evaluation of exercise capacity using 6-Minute Walk Test(Week 8)
- Evaluation of the number of hospitalizations(Month 12)
- Evaluation of anxiety and depressive disorders(Week 8)
- Evaluation of dyspnea with mMRC scale(Week 8)
- Evaluation of dyspnea with Dyspnea-12 questionnaire(Week 8)