Safety test of sensory stimulation treatment for head and neck cancer patients

JRCT ID: jRCTs062220008

Registered date:13/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: head and neck cancer
• Date of first enrollment: 16/06/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

During swallowing rehabilitation, swallowing rehabilitation is performed with the IFCD "Gentle Stim" attached.
[Performing period]
Perform swallowing rehabilitation with IFCD attached for 30 minutes during normal swallowing rehabilitation.
[Performing method]
Attach the IFCD stimulation electrode to the cervical skin.
Turn on the stimulator and set the timer to 30 minutes.
Wear it for 30 minutes of swallowing rehabilitation.
Press the volume up switch, start output at level 1, adjust the intensity while confirming the patient's perception of the stimulus from the electrodes, and maintain the output at a level that does not cause discomfort to the patient.
The maximum output value is 15 (3.4mA), but the output value should be adjusted in consultation with the patient as appropriate.

Outcome(s)

• Primary Outcome: IFCD feasibility rate

Secondary Outcome

Adverse event
General condition, clinical blood data and main nutritional means, nutritional condition
IFCD implementation days, output, usage time
Changes over time in sensation of the pharynx and larynx
Changes over time in swallowing function, sensation of pharynx and larynx, tongue pressure, multi channel surface EMG, QOL questionnaire
Assessing the achievement and efficacy of supportive care for dermatitis

Key inclusion & exclusion criteria

• Age minimum: > 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients undergoing chemoradiation therapy for head and neck cancer at Hiroshima University Hospital
2. Patients who receive 70 Gy of radiation to the primary / laryngo-pharyngeal area
3. Patients over 20 years old at the time of obtaining consent
4. Patients who can obtain written consent from the individual regarding participation in this study

Exclude criteria

1. Patients with a history of radiation therapy in the head and neck area
2. Patients with tracheostomy
3. Patients who irradiate mainly the part other than the laryngo-pharyngeal area
4. Patients with pacemakers and implantable cardioverter-defibrillators
5. Patients who are expected to have difficulty wearing IFCD on the neck
6. Patients with many inconveniences in daily life (Performance Status 2 or higher)
7. Patients who are pregnant, may become pregnant, or breastfeeding
8. In addition, patients who are judged to be inappropriate by the principal investigator or the research coordinator

Related Information

• Primary Sponsor: Hamamoto Takao