Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

NCT00815087 | Completed Phase 2 Results DMC

• 1 other identifier: 200804032R
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dysphagia

Keywords

Nasopharyngeal carcinoma; functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Questionnaire of Life Quality

  1 to 3 months

Study Arms (2)

Functional Electrical Stimulation (FES)

EXPERIMENTAL

Functional electrical stimulation: Experimental

Device: Functional electrical stimulation

Home Rehabilitation Program (HRP)

ACTIVE COMPARATOR

Exercise home program

Behavioral: Exercise home program

Interventions

Functional electrical stimulation DEVICE

15 sessions of VitalStim® therapy, 60 minutes per session

Also known as: VitalStim®

Functional Electrical Stimulation (FES)

Exercise home program BEHAVIORAL

Daily exercise training

Also known as: Range of motion exercises, resistence exercises, etc...

Home Rehabilitation Program (HRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary nasopharyngeal carcinoma
• Post radiation therapy
• Mild to severe dysphagia
• Never underwent swallowing therapy

You may not qualify if:

• Recurrent cancer
• Neurological or degenerate disease
• Total or partial laryngectomy
• Epilepsy
• With cardiac pacemaker

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Deglutition Disorders; Nasopharyngeal Carcinoma

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Lack of information about muscle fibrosis, no control group. and the results from the small amount of subjects.

Results Point of Contact

• Title: Dr.Wang TG
• Organization: Wang tyng

patty.jt@gmail.com

+886-2-23123456

Study Officials

• Tyng-Guey Wang, MD

  Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2008
• First Posted: December 29, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: October 1, 2013
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-03