Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC) - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00815087

Purpose

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

Condition	Intervention	Phase
Dysphagia	Device: Functional electrical stimulation Behavioral: Exercise home program	Phase II

MedlinePlus related topics: Cancer Exercise and Physical Fitness Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Videofluoroscopic study for evaluating swallow function [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Questionnaire of life quality [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Functional electrical stimulation: Experimental	Device: Functional electrical stimulation 15 sessions of VitalStim® therapy, 60 minutes per session
2: Active Comparator Exercise home program	Behavioral: Exercise home program Daily exercise training

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Epilepsy
With cardiac pacemaker

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815087

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Tyng-Guey Wang, MD

Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital ( National Taiwan University Hospital )
Study ID Numbers:	200804032R
Study First Received:	December 25, 2008
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00815087
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Nasopharyngeal carcinoma
functional electrical stimulation

Study placed in the following topic categories:

Deglutition Disorders
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases
Carcinoma

ClinicalTrials.gov processed this record on January 15, 2009