Clinical trial NCT01237704: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Radiotherapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth Hospital, Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2010-11-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: Up to 1 year after rehabilitation program
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)
timeFrame: Up to 1 year after rehabilitation program
measure: Self-rated Swallowing Score
timeFrame: up to 1 year after rehabilitation program
measure: Voice Handicap Index - 30
timeFrame: Up to 1 year after rehabilitation program
measure: Oral Assessment Guide
timeFrame: Up to 1 year after rehabilitation program
measure: Perceptual Evaluation of Voice
timeFrame: Up to 1 year after rehabilitation program
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Michael Tong
role: PRINCIPAL_INVESTIGATOR
References: