Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Chinese University of Hong Kong
Sponsor:
Collaborators:
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Information provided by (Responsible Party):
Michael Tong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01237704
First received: October 28, 2010
Last updated: February 24, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Nasopharyngeal Carcinoma
Radiotherapy
Behavioral: Traditional rehabilitation (TR)
Behavioral: Transcutaneous electrical stimulation (ES)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy: a Randomised-controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Penetration-Aspiration Scale [ Time Frame: Up to 1 year after rehabilitation program ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy - Nasopharyngeal (FACT-NP) [ Time Frame: Up to 1 year after rehabilitation program ] [ Designated as safety issue: No ]

    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.


  • Self-rated Swallowing Score [ Time Frame: up to 1 year after rehabilitation program ] [ Designated as safety issue: No ]
    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.

  • Voice Handicap Index - 30 [ Time Frame: Up to 1 year after rehabilitation program ] [ Designated as safety issue: No ]
    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.

  • Oral Assessment Guide [ Time Frame: Up to 1 year after rehabilitation program ] [ Designated as safety issue: No ]
    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.

  • Perceptual Evaluation of Voice [ Time Frame: Up to 1 year after rehabilitation program ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional rehabilitation (TR) 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.
Active Comparator: Transcutaneous electrical stimulation (ES) Behavioral: Transcutaneous electrical stimulation (ES)
Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237704

Contacts
Contact: Michael Tong, MD +852 2632 2633 mtong@ent.cuhk.edu.hk
Contact: Janice Lin, MBChB janicelin@ent.cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, New Territories, Hong Kong
Contact: Janice Lin, MBChB       janicelin@ent.cuhk.edu.hk   
Contact: Rita Wong       ritawong@ent.cuhk.edu.hk   
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
Contact: Rita Wong       ritawong@ent.cuhk.edu.hk   
Contact: Janice Lin       janicelin@ent.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Investigators
Principal Investigator: Michael Tong Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Michael Tong, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01237704     History of Changes
Other Study ID Numbers: GRF 475210
Study First Received: October 28, 2010
Last Updated: February 24, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Pharyngeal Diseases
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014