Nasopharyngeal CarcinomaNCT01237704
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
A study testing Traditional rehabilitation (TR) and Transcutaneous electrical stimulation (ES) in people with Nasopharyngeal Carcinoma and Radiotherapy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Radiotherapy
- What is being tested?
- Traditional rehabilitation (TR) and Transcutaneous electrical stimulation (ES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesHong Kong
- Study dates
- Jan 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able 18 years of age
- undergone primary radiotherapy or chemoradiotherapy as the treatment
- are expected to complete the 12 month follow-up
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Janice Lin, MBChB contact
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Elizabeth Hospital
Kowloon
Rita Wong, ritawong@ent.cuhk.edu.hk
Janice Lin, janicelin@ent.cuhk.edu.hk
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Janice Lin, MBChB, janicelin@ent.cuhk.edu.hk
Rita Wong, ritawong@ent.cuhk.edu.hk
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Carcinoma, Radiotherapy
- Being tested
- Traditional rehabilitation (TR), Transcutaneous electrical stimulation (ES)
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional rehabilitation (TR)Behavioural
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.
Transcutaneous electrical stimulation (ES)Behavioural
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Traditional rehabilitation (TR) | Active comparator | Not described Receives: Behavioral: Traditional rehabilitation (TR) |
| Transcutaneous electrical stimulation (ES) | Active comparator | Not described Receives: Behavioral: Transcutaneous electrical stimulation (ES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year after rehabilitation program
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year after rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Michael Tong, Chinese University of Hong Kong
- Investigators
- Michael Tong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237704
- Sponsor's protocol ID
- GRF 475210
- Status last verified
- Feb 2013
- First submitted
- 28 Oct 2010
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial
- ClinicalTrials.gov ID
- NCT01237704
- Acronym / sponsor ID
- GRF 475210
- Conditions
- Nasopharyngeal Carcinoma, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional rehabilitation (TR) | Active comparator | Behavioral: Traditional rehabilitation (TR) |
| Transcutaneous electrical stimulation (ES) | Active comparator | Behavioral: Transcutaneous electrical stimulation (ES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able 18 years of age
- undergone primary radiotherapy or chemoradiotherapy as the treatment
- are expected to complete the 12 month follow-up
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Traditional rehabilitation (TR) |
| Transcutaneous electrical stimulation (ES)Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions. | Behavioural | Transcutaneous electrical stimulation (ES) |
Primary outcome
Penetration-Aspiration Scale
Time frame: 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.
5 secondary outcomes
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
Time frame: Up to 1 year after rehabilitation program
Self-rated Swallowing Score
Time frame: up to 1 year after rehabilitation program
Voice Handicap Index - 30
Time frame: Up to 1 year after rehabilitation program
Oral Assessment Guide
Time frame: Up to 1 year after rehabilitation program
Perceptual Evaluation of Voice
Time frame: Up to 1 year after rehabilitation program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Lin, MBChB contact
Michael Tong principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional rehabilitation (TR) and Transcutaneous electrical stimulation (ES) in people with Nasopharyngeal Carcinoma and Radiotherapy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tong, MD (+852 2632 2633, mtong@ent.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (time frame: Up to 1 year after rehabilitation program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.