Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Primary Endpoint
- The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •With cardiac pacemaker
Arms & Interventions
Functional Electrical Stimulation (FES)
Functional electrical stimulation: Experimental
Intervention: Functional electrical stimulation (Device)
Home Rehabilitation Program (HRP)
Exercise home program
Intervention: Exercise home program (Behavioral)
Outcomes
Primary Outcomes
The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
Time Frame: Averaged 2 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 Outcomes
- Questionnaire of Life Quality(1 to 3 months)