Back to resultsFunctional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
Primary Purpose
Dysphagia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Functional electrical stimulation
Exercise home program
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Nasopharyngeal carcinoma, functional electrical stimulation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional Electrical Stimulation (FES)
Home Rehabilitation Program (HRP)
Arm Description
Functional electrical stimulation: Experimental
Exercise home program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Questionnaire of Life Quality
Full Information
NCT ID
NCT00815087
First Posted
December 25, 2008
Last Updated
March 2, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00815087
Brief Title
Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
Official Title
Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Nasopharyngeal carcinoma, functional electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Electrical Stimulation (FES)
Arm Type
Experimental
Arm Description
Functional electrical stimulation: Experimental
Arm Title
Home Rehabilitation Program (HRP)
Arm Type
Active Comparator
Arm Description
Exercise home program
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation
Other Intervention Name(s)
VitalStim®
Intervention Description
15 sessions of VitalStim® therapy, 60 minutes per session
Intervention Type
Behavioral
Intervention Name(s)
Exercise home program
Other Intervention Name(s)
Range of motion exercises, resistence exercises, etc...
Intervention Description
Daily exercise training
Primary Outcome Measure Information:
Title
The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
Description
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.
Time Frame
Averaged 2 months
Secondary Outcome Measure Information:
Title
Questionnaire of Life Quality
Time Frame
1 to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyng-Guey Wang, MD
Organizational Affiliation
Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
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