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

Safety test of transcutaneous electrical sensory stimulation treatment for head and neck cancer patients treated with chemo-radiotherapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs062220008

Enrollment

Registered

2022-04-13

Start date

2022-06-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer head and neck cancer, swallowing dysfunction, chemoradiotherapy, aspiration pneumonia

Interventions

During swallowing rehabilitation, swallowing rehabilitation is performed with the IFCD "Gentle Stim" attached. [Performing period] Perform swallowing rehabilitation with IFCD attached for 30 minutes d

neuromuscular electrical stimulation, transcutaneous electrical sensory stimulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
IFCD feasibility rate	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactTakao Hamamoto

Hiroshima University Hospital

takao0320@hiroshima-u.ac.jp+81-82-257-5252

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026