Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysphagia

Intervention / Treatment
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* Device: Functional electrical stimulation
* Behavioral: Exercise home program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Life Quality |  | 1 to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, functional electrical stimulation