NCT03216863终止不适用
Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy
University Hospital, Lille3 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年8月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •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
排除标准
- •Any residual toxicity of a previous antineoplastic treatment, grade>
- •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
研究组 & 干预措施
8 weeks Respiratory rehabilitation
Experimental
干预措施: Respiratory rehabilitation (Other)
结局指标
主要结局
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
时间窗: At 8 weeks
次要结局
- Functional capacity(Baseline and 8 weeks)
- Body Mass Index(Baseline and 8 weeks)
- EORTC QLQ C-30 standardized version 3.0(Baseline and 8 weeks)
- Overall and progression-free survival(at 6 months)
- Respiratory capacity(Baseline and 8 weeks)
- Functional Assessment of Cancer Therapy Lung standardized(Baseline and 8 weeks)
- Nutritional Risk Screening score(Baseline and 8 weeks)
研究者
研究点 (3)
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