Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

March 2, 2014 updated by: National Taiwan University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Electrical Stimulation (FES)
Functional electrical stimulation: Experimental
Device: Functional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session
Other Names:
  • VitalStim®
Active Comparator: Home Rehabilitation Program (HRP)
Exercise home program
Behavioral: Exercise home program
Daily exercise training
Other Names:
  • Range of motion exercises, resistence exercises, etc...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Averaged 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaire of Life Quality
Time Frame: 1 to 3 months
1 to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Tyng-Guey Wang, MD, Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

December 25, 2008

First Submitted That Met QC Criteria

December 26, 2008

First Posted (Estimate)

December 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 2, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200804032R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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