Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

Phase 2

Completed

• Conditions: Dysphagia
• Interventions: Device: Functional electrical stimulation; Behavioral: Exercise home program

• Registration Number: NCT00815087
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-12-25
• Study First Submitted QC: 2008-12-26
• Study First Posted: 2008-12-29
• Primary Completion: 2009-02
• Study Completion: 2013-10
• Results First Submitted: 2013-11-13
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-02
• Last Update Submitted: 2014-03-02
• Results First Posted: 2014-03-26
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Primary nasopharyngeal carcinoma
• Post radiation therapy
• Mild to severe dysphagia
• Never underwent swallowing therapy

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Exclusion Criteria

• Recurrent cancer
• Neurological or degenerate disease
• Total or partial laryngectomy
• Epilepsy
• With cardiac pacemaker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Electrical Stimulation (FES)	Functional electrical stimulation	Functional electrical stimulation: Experimental
Home Rehabilitation Program (HRP)	Exercise home program	Exercise home program

Primary Outcome Measures

Name	Time	Method
The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months	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 Outcome Measures

Name	Time	Method
Questionnaire of Life Quality	1 to 3 months