Dysphagia
Conditions
Keywords
Nasopharyngeal carcinoma, functional electrical stimulation
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.
Interventions
DEVICEFunctional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session
BEHAVIORALExercise home program
Daily exercise training
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Epilepsy * With cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months | 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
| Measure | Time frame |
|---|---|
| Questionnaire of Life Quality | 1 to 3 months |
Participant flow
Recruitment details
Twenty subjects were referral from department of oncology & physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan. The study was approved by the Ethics Committee of the National Taiwan University Hospital. All participants gave their informed consent.
Pre-assignment details
They were assigned into the FES group and home rehabilitation program (HRP) group by the method of sex stratified randomization, and were matched by Dysphagia Outcome and Severity Scale (DOSS) score within 1 unit in order to compare two groups under the same sex proportion and similar DOSS score pairs.
Participants by arm
| Arm | Count |
|---|---|
| Functional Electrical Stimulation (FES) Functional electrical stimulation: Experimental
Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session | 10 |
| Home Rehabilitation Program (HRP) Exercise home program
Exercise home program : Daily exercise training | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Home Rehabilitation Program (HRP) | Functional Electrical Stimulation (FES) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 56.1 years STANDARD_DEVIATION 11.8 | 52.3 years STANDARD_DEVIATION 7.4 | 54.2 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Taiwan | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Averaged 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functional Electrical Stimulation (FES) | The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months | 0.8 cm/s | Standard Deviation 0.5 |
| Home Rehabilitation Program (HRP) | The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months | -0.4 cm/s | Standard Deviation 0.8 |
Secondary
Questionnaire of Life Quality
Time frame: 1 to 3 months