Clinical Trial: 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 (Japan)

Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060415) titled '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' on Jan. 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - Fukuoka University Hospital

Condition: Condition - Head and Neck Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Confirm the safety of transcutaneous neuromuscular electrical stimulation (NMES) for head and neck cancer patients. Basic objectives2 - Safety

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 09 Day Anticipated trial start date - 2026 Year 01 Month 21 Day Last follow-up date - 2027 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069114

Disclaimer: Curated by HT Syndication.