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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (予想される)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Michael Tong, MD
- 電話番号：+852 2632 2633
- メール：mtong@ent.cuhk.edu.hk
研究連絡先のバックアップ
- 名前：Janice Lin, MBChB
- メール：janicelin@ent.cuhk.edu.hk
研究場所
-
-
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Kowloon、香港
- 募集
- Queen Elizabeth Hospital
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コンタクト：
- Rita Wong
- メール：ritawong@ent.cuhk.edu.hk
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コンタクト：
- Janice Lin
- メール：janicelin@ent.cuhk.edu.hk
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New Territories
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Shatin、New Territories、香港
- 募集
- Prince of Wales Hospital
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コンタクト：
- Janice Lin, MBChB
- メール：janicelin@ent.cuhk.edu.hk
-
コンタクト：
- Rita Wong
- メール：ritawong@ent.cuhk.edu.hk
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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アクティブコンパレータ：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.
|
|
アクティブコンパレータ：Transcutaneous electrical stimulation (ES)
|
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Penetration-Aspiration Scale
時間枠：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. |
Up to 1 year after rehabilitation program
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
時間枠：Up to 1 year after rehabilitation program
|
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
|
|
Self-rated Swallowing Score
時間枠：up to 1 year after rehabilitation program
|
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.
|
up to 1 year after rehabilitation program
|
|
Voice Handicap Index - 30
時間枠：Up to 1 year after rehabilitation program
|
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.
|
Up to 1 year after rehabilitation program
|
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Oral Assessment Guide
時間枠：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.
|
Up to 1 year after rehabilitation program
|
|
Perceptual Evaluation of Voice
時間枠：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.
|
Up to 1 year after rehabilitation program
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Michael Tong、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始
研究開始
一次修了 (予想される)
一次修了
研究の完了 (予想される)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
最初の投稿
学習記録の更新
投稿された最後の更新 (見積もり)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
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