Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os
Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy
The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.
These patients will benefit, at the beginning of the chemotherapy whatever the treatment line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions. There is associated educational, nutritional and psychological support for a total duration of 8 weeks.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Lille、法国
- Hôpital Calmette, CHRU
-
Lille、法国
- Hôpital Privé La Louvière
-
Roubaix、法国
- Centre hospitalier Victor Provo
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient with advanced or metastatic lung cancer
- In the course of treatment by oral chemotherapy of oral targeted therapy (tyrosine kinase inhibitor) in 1st, 2nd, 3rd line or more at the time of their inclusion
- Diagnosis of CP retained after multidisciplinary discussion of patient records
Exclusion Criteria:
- Any residual toxicity of a previous antineoplastic treatment, grade> 2.
- Cardio-respiratory contraindications to exercise re-training:
- Angina unstable
- Recent infarct
- Tight aortic stenosis
- Unsteady heart failure
- Pericarditis, endocarditis, myocarditis
- Evolutionary thromboembolic disease
- Ventricular aneurysm
- Intra ventricular thrombus
- Uncontrolled rhythm disorders
- Instability of the respiratory state defined by uncompensated respiratory acidosis
- Carcinological contraindications:
- Bone metastases at risk of fracture and / or algae despite optimal analgesic treatment, symptomatic central nervous system metastases
- Presence of anemia (Hb <8g / dl or <10g / dl if patient with previous cardiac history), thrombocytopenia (<100,000 platelets / mm3)
- Chimio toxicity (neurological, cardiac) according to the investigator's assessment
- Neuromuscular contraindications:
- Neuromuscular and / or osteo-articular disease making it impossible to re-train
- Severe cognitive impairment
- Patient under tutorship or curatorship
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:8 weeks Respiratory rehabilitation
|
It consists of a global care of the patient: therapeutic education, nutritional maintenance, psychological support and re-training to the effort at home after discharge or after follow up visit of targeted therapy
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
大体时间:At 8 weeks
|
At 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Functional Assessment of Cancer Therapy Lung standardized
大体时间:Baseline and 8 weeks
|
measure the quality of life
|
Baseline and 8 weeks
|
EORTC QLQ C-30 standardized version 3.0
大体时间:Baseline and 8 weeks
|
Measure the quality of life
|
Baseline and 8 weeks
|
Functional capacity
大体时间:Baseline and 8 weeks
|
Exercise capacity with the six minutes walk test
|
Baseline and 8 weeks
|
Respiratory capacity
大体时间:Baseline and 8 weeks
|
measured by the spirometry
|
Baseline and 8 weeks
|
Nutritional Risk Screening score
大体时间:Baseline and 8 weeks
|
Nutritional state assessment by albumine and pre albumine dosage
|
Baseline and 8 weeks
|
Body Mass Index
大体时间:Baseline and 8 weeks
|
Baseline and 8 weeks
|
|
Overall and progression-free survival
大体时间:at 6 months
|
at 6 months
|
合作者和调查者
调查人员
- 首席研究员:Arnaud Scherpereel, MD, PhD、University Hospital, Lille
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Respiratory rehabilitation的临床试验
-
IRCCS Eugenio Medea招聘中