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


N/A
18 Years
N/A
Open (Enrolling)
Both
Nasopharyngeal Carcinoma, Radiotherapy

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Penetration-Aspiration Scale

Outcome Description:

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.

Outcome Time Frame:

Up to 1 year after rehabilitation program

Safety Issue:

Yes

Principal Investigator

Michael Tong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

GRF 475210

NCT ID:

NCT01237704

Start Date:

January 2011

Completion Date:

December 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Radiotherapy
  • Carcinoma
  • Deglutition Disorders
  • Nasopharyngeal Neoplasms

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