Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00815087
First received: December 25, 2008
Last updated: March 2, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether functional electrical stimulation is effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy


Condition Intervention Phase
Dysphagia
Device: Functional electrical stimulation
Behavioral: Exercise home program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months [ Time Frame: Averaged 2 months ] [ Designated as safety issue: Yes ]
    A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.


Secondary Outcome Measures:
  • Questionnaire of Life Quality [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: October 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Electrical Stimulation (FES)
Functional electrical stimulation: Experimental
Device: Functional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session
Other Name: VitalStim®
Active Comparator: Home Rehabilitation Program (HRP)
Exercise home program
Behavioral: Exercise home program
Daily exercise training
Other Name: Range of motion exercises, resistence exercises, etc...

Detailed Description:

Nasopharyngeal carcinoma (NPC) patients usually underwent radiotherapy (RT) or chemoradiotherapy(CRT). There were some complications caused by RT, like dysphagia.

In recent studies, functional electrical stimulation (FES) was be used in neurologically dysphagia patients, and there were some positive effects with these studies. Hence, we decided applied FES to these NPC patients with dysphagia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary nasopharyngeal carcinoma
  • Post radiation therapy
  • Mild to severe dysphagia
  • Never underwent swallowing therapy

Exclusion Criteria:

  • Recurrent cancer
  • Neurological or degenerate disease
  • Total or partial laryngectomy
  • Epilepsy
  • With cardiac pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815087

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Tyng-Guey Wang, MD Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00815087     History of Changes
Other Study ID Numbers: 200804032R
Study First Received: December 25, 2008
Results First Received: November 13, 2013
Last Updated: March 2, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Nasopharyngeal carcinoma
functional electrical stimulation

Additional relevant MeSH terms:
Deglutition Disorders
Nasopharyngeal Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2014