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Completed

NCT Number: NCT00815087

Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

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

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Key information

Conditions

Dysphagia Carcinoma Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional electrical stimulation

Device

15 sessions of VitalStim® therapy, 60 minutes per session

Other names: VitalStim®

Exercise home program

Behavioral

Daily exercise training

Other names: Range of motion exercises, resistence exercises, etc...

Primary outcomes

  1. 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

  1. Questionnaire of Life Quality

    Time frame: 1 to 3 months

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Dec 29, 2008
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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