Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815087
Recruitment Status : Completed
First Posted : December 29, 2008
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
National Taiwan University Hospital

December 25, 2008
December 29, 2008
November 13, 2013
March 26, 2014
March 26, 2014
July 2008
February 2009   (Final data collection date for primary outcome measure)
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 ]
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.
Videofluoroscopic study for evaluating swallow function [ Time Frame: 1 to 3 months ]
Complete list of historical versions of study NCT00815087 on Archive Site
Questionnaire of Life Quality [ Time Frame: 1 to 3 months ]
Same as current
Not Provided
Not Provided
Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy
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

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Device: Functional electrical stimulation
    15 sessions of VitalStim® therapy, 60 minutes per session
    Other Name: VitalStim®
  • Behavioral: Exercise home program
    Daily exercise training
    Other Name: Range of motion exercises, resistence exercises, etc...
  • Experimental: Functional Electrical Stimulation (FES)
    Functional electrical stimulation: Experimental
    Intervention: Device: Functional electrical stimulation
  • Active Comparator: Home Rehabilitation Program (HRP)
    Exercise home program
    Intervention: Behavioral: Exercise home program
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2013
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Tyng-Guey Wang, MD Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital
National Taiwan University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP