- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01237704
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michael Tong, MD
- Número de telefone: +852 2632 2633
- E-mail: mtong@ent.cuhk.edu.hk
Estude backup de contato
- Nome: Janice Lin, MBChB
- E-mail: janicelin@ent.cuhk.edu.hk
Locais de estudo
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Kowloon, Hong Kong
- Recrutamento
- Queen Elizabeth Hospital
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Contato:
- Rita Wong
- E-mail: ritawong@ent.cuhk.edu.hk
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Contato:
- Janice Lin
- E-mail: janicelin@ent.cuhk.edu.hk
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New Territories
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Shatin, New Territories, Hong Kong
- Recrutamento
- Prince of Wales Hospital
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Contato:
- Janice Lin, MBChB
- E-mail: janicelin@ent.cuhk.edu.hk
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Contato:
- Rita Wong
- E-mail: ritawong@ent.cuhk.edu.hk
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Penetration-Aspiration Scale
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Tong, Chinese University of Hong Kong
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Neoplasias de Cabeça e Pescoço
- Doenças Nasofaríngeas
- Doenças Faríngeas
- Doenças estomatognáticas
- Doenças Otorrinolaringológicas
- Neoplasias Nasofaríngeas
- Carcinoma
- Carcinoma nasofaringeal
Outros números de identificação do estudo
- GRF 475210
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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