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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00815087 |
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 |
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 |
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 |
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1: Experimental
Functional electrical stimulation: Experimental
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Device: Functional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session
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2: Active Comparator
Exercise home program
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Behavioral: Exercise home program
Daily exercise training
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Nasopharyngeal carcinoma functional electrical stimulation |
Deglutition Disorders Nasopharyngeal carcinoma Otorhinolaryngologic Diseases Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases Carcinoma |