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

December 25, 2008
March 2, 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 ] [ 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.
Videofluoroscopic study for evaluating swallow function [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00815087 on ClinicalTrials.gov Archive Site
Questionnaire of Life Quality [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dysphagia
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00815087
200804032R
Yes
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