DysphagiaPhase 2NCT00815087

Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

A Phase 2 study testing Functional electrical stimulation and Exercise home program in people with Dysphagia, run by National Taiwan University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Functional electrical stimulation and Exercise home program
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Jul 2008to Oct 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy

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

Read the 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.

Conditions: Dysphagia
Being tested: Functional electrical stimulation, Exercise home program
Keywords: Nasopharyngeal carcinoma, functional electrical stimulation
Medical subject headings: Deglutition Disorders, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional electrical stimulationDevice
Also called VitalStim®
15 sessions of VitalStim® therapy, 60 minutes per session
Exercise home programBehavioural
Also called Range of motion exercises, resistence exercises, etc...
Daily exercise training

Study groups in NCT00815087
Study group	Role	What they receive
Functional Electrical Stimulation (FES)	Experimental	Functional electrical stimulation: Experimental Receives: Device: Functional electrical stimulation
Home Rehabilitation Program (HRP)	Active comparator	Exercise home program Receives: Behavioral: Exercise home program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Averaged 2 months

Secondary outcomes (1)

Questionnaire of Life Quality
Measured: 1 to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Oct 2013

First posted29 Dec 2008 (estimated)
Study startJul 2008
Primary completionFeb 2009
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00815087
Sponsor's protocol ID: 200804032R
Status last verified: Mar 2014
First submitted: 25 Dec 2008
Last updated: 26 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy
ClinicalTrials.gov ID: NCT00815087
Acronym / sponsor ID: 200804032R
Conditions: Dysphagia
Keywords: Nasopharyngeal carcinoma, functional electrical stimulation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: Jul 2008
Primary completion: Feb 2009 (actual)
Study completion: Oct 2013 (actual)
First posted: 29 Dec 2008 (estimated)
Results: Posted 26 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Functional Electrical Stimulation (FES)	Experimental	Device: Functional electrical stimulationFunctional electrical stimulation: Experimental
Home Rehabilitation Program (HRP)	Active comparator	Behavioral: Exercise home programExercise home program

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Functional electrical stimulationAlso: VitalStim®15 sessions of VitalStim® therapy, 60 minutes per session	Device	Functional Electrical Stimulation (FES)
Exercise home programAlso: Range of motion exercises, resistence exercises, etc...Daily exercise training	Behavioural	Home Rehabilitation Program (HRP)

Primary outcome

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.

1 secondary outcome

Questionnaire of Life Quality
Time frame: 1 to 3 months

Results and safety

Results posted to the registry on 26 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Functional Electrical Stimulation (FES)	10	10
Home Rehabilitation Program (HRP)	10	10

Primary outcome: 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. Mean (Standard Deviation). Unit: cm/s

Measure	Functional Electrical Stimulation (FES) n = 10	Home Rehabilitation Program (HRP) n = 10
Value	0.8 (0.5)	-0.4 (0.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The data were collected from cut point VFSS to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Functional Electrical Stimulation (FES)	0 of 10 (0%)	0 of 10 (0%)	Not reported
Home Rehabilitation Program (HRP)	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Lack of information about muscle fibrosis, no control group. and the results from the small amount of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
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Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tyng-Guey Wang, MD principal investigator

Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Functional electrical stimulation and Exercise home program in people with Dysphagia, run by National Taiwan University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00815087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.