Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

NCT01237704 | Unknown DMC

• 1 other identifier: GRF 475210
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasopharyngeal Carcinoma; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP)

  Up to 1 year after rehabilitation program

• Self-rated Swallowing Score

  up to 1 year after rehabilitation program

• Voice Handicap Index - 30

  Up to 1 year after rehabilitation program

• Oral Assessment Guide

  Up to 1 year after rehabilitation program

• Perceptual Evaluation of Voice

  Up to 1 year after rehabilitation program

Study Arms (2)

Traditional rehabilitation (TR)

ACTIVE COMPARATOR

Behavioral: Traditional rehabilitation (TR)

Transcutaneous electrical stimulation (ES)

ACTIVE COMPARATOR

Behavioral: Transcutaneous electrical stimulation (ES)

Interventions

Traditional rehabilitation (TR) BEHAVIORAL

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.

Traditional rehabilitation (TR)

Transcutaneous electrical stimulation (ES) BEHAVIORAL

Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

Transcutaneous electrical stimulation (ES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able 18 years of age
• undergone primary radiotherapy or chemoradiotherapy as the treatment
• are expected to complete the 12 month follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Queen Elizabeth Hospital, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (2)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Queen Elizabeth Hospital

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Michael Tong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tong, MD

CONTACT

+852 2632 2633; mtong@ent.cuhk.edu.hk

Janice Lin, MBChB

CONTACT

janicelin@ent.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 10, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

HK (2)