Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
Primary Purpose
Nasopharyngeal Carcinoma, Radiotherapy
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Traditional rehabilitation (TR)
Transcutaneous electrical stimulation (ES)
Sponsored by

About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
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
Sites / Locations
- Prince of Wales HospitalRecruiting
- Queen Elizabeth HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traditional rehabilitation (TR)
Transcutaneous electrical stimulation (ES)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01237704
First Posted
October 28, 2010
Last Updated
February 24, 2013
Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01237704
Brief Title
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
Official Title
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional rehabilitation (TR)
Arm Type
Active Comparator
Arm Title
Transcutaneous electrical stimulation (ES)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Traditional rehabilitation (TR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transcutaneous electrical stimulation (ES)
Intervention Description
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.
Primary Outcome Measure Information:
Title
Penetration-Aspiration Scale
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.
Time Frame
Up to 1 year after rehabilitation program
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
Description
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.
Time Frame
Up to 1 year after rehabilitation program
Title
Self-rated Swallowing Score
Description
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.
Time Frame
up to 1 year after rehabilitation program
Title
Voice Handicap Index - 30
Description
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.
Time Frame
Up to 1 year after rehabilitation program
Title
Oral Assessment Guide
Description
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.
Time Frame
Up to 1 year after rehabilitation program
Title
Perceptual Evaluation of Voice
Description
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.
Time Frame
Up to 1 year after rehabilitation program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tong, MD
Phone
+852 2632 2633
Email
mtong@ent.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Janice Lin, MBChB
Email
janicelin@ent.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Tong
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice Lin, MBChB
Email
janicelin@ent.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Rita Wong
Email
ritawong@ent.cuhk.edu.hk
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Wong
Email
ritawong@ent.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Janice Lin
Email
janicelin@ent.cuhk.edu.hk
12. IPD Sharing Statement
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Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
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