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.

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma; Radiotherapy
• Intervention / Treatment: Behavioral: Traditional rehabilitation (TR); Behavioral: Transcutaneous electrical stimulation (ES)

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Queen Elizabeth Hospital
    • Contact: Rita Wong; Email: ritawong@ent.cuhk.edu.hk
    • Contact: Janice Lin; Email: janicelin@ent.cuhk.edu.hk
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Janice Lin, MBChB; Email: janicelin@ent.cuhk.edu.hk
      • Contact: Rita Wong; Email: ritawong@ent.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional rehabilitation (TR)	Behavioral: 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.
Active Comparator: Transcutaneous electrical stimulation (ES)	Behavioral: Transcutaneous electrical stimulation (ES); Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration-Aspiration Scale	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Prince of Wales Hospital, Shatin, Hong Kong
• Investigators: Principal Investigator: Michael Tong, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 24, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: GRF 475210