NCT00332865已完成1 期
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
研究概览
简要总结
Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H&N35 questionnaire. Weight loss, duration of tube feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Head and neck cancer
- •Planned curative radiotherapy
- •Planned irradiation of level II+III lymph nodes >46 Gy
- •Speaks and reads Danish
- •No previous Surgery to the head and neck area except biopsies
排除标准
- 未提供
结局指标
主要结局
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
时间窗: 2 mths
次要结局
- Weight(2 mths)
- Duration of tube feeding(2 mths)
- Swallowing scale of EORTC HN 35(2 mths)
研究者
Kenneth Jensen
MD ph.d.
University of Aarhus
研究点 (2)
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