Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

NCT ID: NCT00815087

Last Updated: 2014-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-10-31

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.

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Functional Electrical Stimulation (FES)

Functional electrical stimulation: Experimental

Group Type EXPERIMENTAL

Functional electrical stimulation

Intervention Type DEVICE

15 sessions of VitalStim® therapy, 60 minutes per session

Home Rehabilitation Program (HRP)

Exercise home program

Group Type ACTIVE_COMPARATOR

Exercise home program

Intervention Type BEHAVIORAL

Daily exercise training

Interventions

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Functional electrical stimulation

15 sessions of VitalStim® therapy, 60 minutes per session

Intervention Type DEVICE

Exercise home program

Daily exercise training

Intervention Type BEHAVIORAL

Other Intervention Names

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VitalStim® Range of motion exercises, resistence exercises, etc...

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyng-Guey Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital

Other Identifiers

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200804032R

Identifier Type: -

Identifier Source: org_study_id

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