Brief Title
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy
Official Title
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial
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.
Study Type
Interventional
Primary Outcome
Penetration-Aspiration Scale
Secondary Outcome
Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
Condition
Nasopharyngeal Carcinoma
Intervention
Traditional rehabilitation (TR)
Study Arms / Comparison Groups
Traditional rehabilitation (TR)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
160
Start Date
January 2011
Completion Date
December 2014
Primary Completion Date
June 2014
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michael Tong, +852 2632 2633, [email protected]
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT01237704
Organization ID
GRF 475210
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong
Study Sponsor
Michael Tong, Principal Investigator, Chinese University of Hong Kong
Verification Date
February 2013