Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01237704
• Other study ID #: GRF 475210
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2010
• Last updated: February 24, 2013
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2013
• Source: Chinese University of Hong Kong
• Contact: Michael Tong, MD
• Phone: +852 2632 2633
• Email: mtong[@]ent.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Radiotherapy

Intervention

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.
• Transcutaneous electrical stimulation (ES)
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Kowloon
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No