UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060415 |
|---|---|
| Receipt number | R000069114 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/20 18:49:18 |
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Basic information
Public title
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
Acronym
Research on Transcutaneous Neuromuscular Electrical Stimulation Devices
Scientific Title
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
Scientific Title:Acronym
Single-center randomized controlled trial
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Confirm the safety of transcutaneous neuromuscular electrical stimulation (NMES) for head and neck cancer patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of the Maximum Current Ensuring Safety for Electrical Stimulation of the Swallowing Musculature in GentleStim EX
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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 head and neck cancer patients undergoing radiation therapy or chemoradiation therapy five times per week on weekdays for 15 minutes per session. Track patients from baseline before treatment until the end of radiation therapy.
The severity grades of dermatitis and mucositis, pain scale, presence or absence of symptoms such as transvenous sinus syndrome and vasovagal syncope, presence or absence of taste disturbance, and presence or absence of dysphagia signs were monitored and evaluated from the start to the completion of radiation therapy.
Interventions/Control_2
The severity grades of dermatitis and mucositis, pain scale, presence or absence of symptoms such as transvenous sinus syndrome and vasovagal syncope, presence or absence of taste disturbance, and presence or absence of dysphagia signs were monitored and evaluated from the start to the completion of radiation therapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key 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.
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ono |
Organization
Fukuoka University Hospital
Division name
Rehabilitation Department
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City
TEL
0928011011
onotakuya0@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ono |
Organization
Fukuoka University Hospital
Division name
Rehabilitation Department
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City
TEL
0928011011
Homepage URL
onotakuya0@gmail.com
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Takuya Ono
Funding Source
Organization
Soda Toyoji Memorial Foundation Research Grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University School of Medicine Department of Bioethics and Medical Ethics
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Fukuoka
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069114
