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临床试验/NCT01237704
NCT01237704Unknown不适用

Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Penetration-Aspiration Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • able 18 years of age
  • undergone primary radiotherapy or chemoradiotherapy as the treatment
  • are expected to complete the 12 month follow-up

排除标准

  • 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

结局指标

主要结局

Penetration-Aspiration Scale

时间窗: Up to 1 year after rehabilitation program

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.

次要结局

  • Self-rated Swallowing Score(up to 1 year after rehabilitation program)
  • Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)(Up to 1 year after rehabilitation program)
  • Voice Handicap Index - 30(Up to 1 year after rehabilitation program)
  • Oral Assessment Guide(Up to 1 year after rehabilitation program)
  • Perceptual Evaluation of Voice(Up to 1 year after rehabilitation program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Tong

Professor

Chinese University of Hong Kong

研究点 (2)

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