Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

Dysphagia Clinical Trial

Official title:

Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815087
• Other study ID #: 200804032R
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2008
• Last updated: March 2, 2014
• Start date: July 2008
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• Functional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session

Behavioral:
• Exercise home program
Daily exercise training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Averaged 2 months	Yes
Secondary	Questionnaire of Life Quality		1 to 3 months	Yes