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Clinical Trials/NCT00815087
NCT00815087
Completed
Phase 2

Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy

National Taiwan University Hospital0 sites20 target enrollmentJuly 2008
ConditionsDysphagia

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dysphagia
Sponsor
National Taiwan University Hospital
Enrollment
20
Primary Endpoint
The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
October 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • With cardiac pacemaker

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Questionnaire of Life Quality(1 to 3 months)

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