Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial
In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal carcinoma (NPC). With early detection and advances in medical care, the number of NPC survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia. Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration, malnutrition and limitations to concurrent treatment such as oral medication. Given the existing large costs NPC patients incur to the healthcare system, dysphagia only serves to further inflate the soaring costs.
In an attempt to reduce dysphagia related costs to the healthcare system, swallowing rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation approaches are commonly adopted. The first is traditional rehabilitation, which involves patients performing various oropharyngeal exercises aimed at improving swallowing physiology. The other swallowing rehabilitation approach is transcutaneous electrical stimulation, which entails using small amount of electric current to increase muscle strength while patients are engaged in swallowing activities. These two methods are proven as effective in patients with stroke and head and neck carcinoma patients. Neither of these methods, nevertheless, yields any efficacy studies in treating NPC patients. Yet, clinicians continue to use either one or both rehabilitation methods as swallowing rehabilitation.
This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC patients post radiotherapy. The research results should provide justification for rehabilitation time, clinicians' efforts, costs involved and resources used in rehabilitating the swallowing difficulties of the NPC patients.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Michael Tong, MD
- 电话号码:+852 2632 2633
- 邮箱:mtong@ent.cuhk.edu.hk
研究联系人备份
- 姓名:Janice Lin, MBChB
- 邮箱:janicelin@ent.cuhk.edu.hk
学习地点
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Kowloon、香港
- 招聘中
- Queen Elizabeth Hospital
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接触:
- Rita Wong
- 邮箱:ritawong@ent.cuhk.edu.hk
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接触:
- Janice Lin
- 邮箱:janicelin@ent.cuhk.edu.hk
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New Territories
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Shatin、New Territories、香港
- 招聘中
- Prince of Wales Hospital
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接触:
- Janice Lin, MBChB
- 邮箱:janicelin@ent.cuhk.edu.hk
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接触:
- Rita Wong
- 邮箱:ritawong@ent.cuhk.edu.hk
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-
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:
- able 18 years of age
- undergone primary radiotherapy or chemoradiotherapy as the treatment
- are expected to complete the 12 month follow-up
Exclusion Criteria:
- prior history of head and neck surgery except biopsies of the NP or the neck nodes
- previous history or having a concurrent neoplasm other than NPC
- other severe medical problems that might contribute to dysphagia, e.g. cerebral vascular accident, neuromuscular diseases, respiratory diseases that may cause dysphagia
- present contraindications for the use of electrical stimulation which include pregnancy, pacemaker, other implanted electrodes or significant reflux
- non-oral feeding is contemplated in prior to treatment
- inability to complete the assessment including cognitive impairment
- of a low life expectancy related to NPC or other illnesses
- history of dysphagia prior to radiotherapy or chemoradiotherapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Traditional rehabilitation (TR)
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TR rehabilitation will be scheduled three 45-minute sessions per week for 4 weeks with a total of 12 sessions that include Mendelsohn manoeuvre, Shaker's exercise, Effortful swallow and Masako manoeuvre.
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有源比较器:Transcutaneous electrical stimulation (ES)
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Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Penetration-Aspiration Scale
大体时间:Up to 1 year after rehabilitation program
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Each subject will undergo Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to identify penetration and aspiration risks of each consistency. Subjects will be assessed on five different consistencies: thin fluids, honey-thick fluids, pureed diet, soft diet and biscuits. Therefore, five penetration-aspiration scores will be generated for each assessment. Scores will be obtained at baseline, post rehabilitation, six months after baseline and one year after baseline for comparison. |
Up to 1 year after rehabilitation program
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
大体时间:Up to 1 year after rehabilitation program
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The validated FACT-NP is a Chinese QOL questionnaire that evaluates the rehabilitation outcomes specifically for NPC patients. Among the sixteen NPC sub-scale items, seven are specific to dysphagia. The total score and dysphagia specific scores will be analysed. Scores will be obtained at baseline, post rehabilitation, six months after baseline and one year after baseline for comparison. |
Up to 1 year after rehabilitation program
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Self-rated Swallowing Score
大体时间:up to 1 year after rehabilitation program
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A questionnaire based on patient's perception of existing feeding difficulties.
Scores will be obtained at baseline, post rehabilitation, six months after baseline and one year after baseline for comparison.
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up to 1 year after rehabilitation program
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Voice Handicap Index - 30
大体时间:Up to 1 year after rehabilitation program
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This self-assessment scale consists of 30 items that measures the voice-related quality-of-life over three domains: functional, physical, and emotional.
Scores will be obtained at baseline, post rehabilitation, six months after baseline and one year after baseline for comparison.
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Up to 1 year after rehabilitation program
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Oral Assessment Guide
大体时间:Up to 1 year after rehabilitation program
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This 24 point tool comprise of eight categories: swallow, voice, lips, saliva, tongue, gingival, teeth and mucous membrane.
Each category is rated by a scale of 1 (normal), 2 (some abnormality) and 3 (severely abnormal).
Scores can be obtained at baseline, post rehabilitation, six months after baseline and one year after baseline for comparison.
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Up to 1 year after rehabilitation program
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Perceptual Evaluation of Voice
大体时间:Up to 1 year after rehabilitation program
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Four vocal parameters, overall severity, roughness, breathiness and strain, will be rated on a 10-point equal-appearing interval scale by the attending speech therapists.
Scores will be obtained at all 4 assessment time point for comparison.
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Up to 1 year after rehabilitation program
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合作者和调查者
调查人员
- 首席研究员:Michael Tong、Chinese University of Hong Kong
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Traditional rehabilitation (TR)的临床试验
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Czech Technical University in PragueUniversity Hospital, Motol招聘中
-
IRCCS Eugenio Medea招聘中
-
Terumo Medical CorporationMedical University of South Carolina完全的
-
VA Long Beach Healthcare System完全的