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Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

24 de febrero de 2013 actualizado por: Michael Tong, Chinese University of Hong Kong

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

160

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Michael Tong, MD
  • Número de teléfono: +852 2632 2633
  • Correo electrónico: mtong@ent.cuhk.edu.hk

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Traditional rehabilitation (TR)
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.
Comparador activo: Transcutaneous electrical stimulation (ES)
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Penetration-Aspiration Scale
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Oral Assessment Guide
Periodo de tiempo: Up to 1 year after rehabilitation program
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
Periodo de tiempo: Up to 1 year after rehabilitation program
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Michael Tong, Chinese University of Hong Kong

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2011

Finalización primaria (Anticipado)

1 de junio de 2014

Finalización del estudio (Anticipado)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

28 de octubre de 2010

Primero enviado que cumplió con los criterios de control de calidad

9 de noviembre de 2010

Publicado por primera vez (Estimar)

10 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de febrero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

24 de febrero de 2013

Última verificación

1 de febrero de 2013

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Traditional rehabilitation (TR)

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