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临床试验/NCT01937793
NCT01937793已完成不适用

Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change from Baseline in videofluoroscopic swallowing study (VFSS)

研究概览

简要总结

This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise programs for patients with NPC after radiation therapy. This study also compares two different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one can bring more benefits to patients after a certain period of exercise training. Three assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful swallowing exercise would have better treatment efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with NPC
  • completed radiation therapy at least 1 year
  • mild to moderate swallowing disorder defined by videofluorography
  • able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions

排除标准

  • feeding tube insitu
  • received pharyngeal surgery
  • tracheostomy tube insitu
  • patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing
  • severe swallowing disorder or aspirate defined by videofluorography
  • other malignances, neurovascular disease, demyelinating disease
  • cancer relapse or metastases

结局指标

主要结局

Change from Baseline in videofluoroscopic swallowing study (VFSS)

时间窗: Change from Baseline in VFSS at 8 weeks

Videofluoroscopic swallowing study (VFSS) measures the bolus transit time including: 1.oral transit time; 2. pharyngeal transit time; and 3. pharyngeal delay time. It also reveals the occurrence of swallowing aspiration or not.

次要结局

  • Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)(Change from Baseline in CSWAL-QOL at 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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