NCT02135185已完成2 期
Phase II Study, Multicentric, Randomized Studying the Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- measurement of the increase of initial endurance
研究概览
简要总结
Improvement exercise tolerance
详细描述
This study allows improved exercise tolerance in patients undergoing rehabilitation effort
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor squamous cell head and neck (excluding nasopharynx) nonmetastatic including cervical lymphadenopathy primitives
- •Patient to be treated with curative radiotherapy monofractionnée for at least 6 weeks, with or without concurrent chemotherapy (including targeted therapies)
排除标准
- •Cancer of the nasopharynx
- •Metastatic Patient
- •Patients who received neoadjuvant chemotherapy or induction
- •Patient parenteral nutrition
- •Non-compliant Patient Treatment
- •Patient with a cons-indication to the achievement of an effort: clinical signs of pulmonary arterial hypertension (PAH) uncontrolled heart failure, recent myocardial infarction, arrhythmias, unstable angina.
- •Patient desaturation in the stress test
- •Patient already included in another clinical trial with an experimental molecule
- •Pacemaker or defibrillator or neurostimulator
- •Contraindications to treatment with standard radiotherapy with or without concurrent chemotherapy
研究组 & 干预措施
Rehabilitation effort
Experimental
custom work endurance combining dietary management adapted to the nutritional status and an APA. Included patients benefit from support for 19 weeks from the start of treatment
干预措施: custom work endurance (Other)
Control
Active Comparator
Control with dietary management adapted to the nutritional status
干预措施: dietary management adapted to the nutritional status (Behavioral)
结局指标
主要结局
measurement of the increase of initial endurance
时间窗: up to 24 weeks
Patients increasing rate of at least 40% of their initial endurance time 3 months after the completion of radiotherapy
次要结局
- Quality of life(3 months after the end of radiotherapy)
研究者
研究点 (2)
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