Safety Evaluation of a Transcutaneous Neuromuscular Electrical Stimulation Device Used to Prevent Atrophy of the Swallowing Muscle Group in Head and Neck Cancer Patients Undergoing Chemoradiotherapy

A Single-Center Randomized Controlled Study on the Safety of a Transcutaneous Neuromuscular Electrical Stimulation Device Used to Prevent Atrophy of the Swallowing Muscle Group in Head and Neck Cancer Patients Undergoing Chemoradiotherapy - Single-center randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060415

Enrollment

Registered

2026-01-21

Start date

2026-01-21

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

Interventions

Use the GentleStim EX low-frequency interferential therapy device (Medical Device Certification No. 306AHBZX00044000) within its approved medical device scope. Apply the muscle contraction mode to hea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients admitted to the Otolaryngology-Head and Neck Surgery ward at Fukuoka University Hospital to undergo radiation therapy or chemoradiation therapy for head and neck cancer.

Exclusion criteria

Exclusion criteria: Individuals undergoing surgical treatment Individuals with a history of carotid sinus syndrome or vasovagal syncope Individuals with arrhythmia Individuals with an infection Individuals with dementia Individuals with a history of convulsive disorders such as epilepsy Individuals with venous or arterial thrombosis Individuals with an implanted pacemaker or implantable cardioverter-defibrillator (ICD) Pregnant women or women who have recently given birth

Design outcomes

Primary

Measure	Time frame
Determination of the Maximum Current Ensuring Safety for Electrical Stimulation of the Swallowing Musculature in GentleStim EX	—

Secondary

Measure	Time frame
Skin inflammation and mucosal inflammation severity grades, pain scale, presence or absence of symptoms via observation and evaluation for transvenous sinus syndrome and vasovagal syncope, presence or absence of taste disorders, presence or absence of dysphagia signs.	—

Countries

Japan

Contacts

Public ContactTakuya Ono

Fukuoka University Hospital Rehabilitation Department

onotakuya0@gmail.com0928011011

Outcome results

None listed

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