head and neck cancer head and neck cancer, swallowing dysfunction, chemoradiotherapy, aspiration pneumonia
Conditions
Interventions
Provide thorough guidance on the operation and management of the Gentle stim device. Loan the Gentle stim device to participants for approximately one month to facilitate at home implementation and ma
neuromuscular electrical stimulation, transcutaneous electrical sensory nerve stimulation
Sponsors
Hamamoto Takao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a history of definitive chemoradiotherapy for head and neck cancer. Patients who have received a curative dose of radiation to the pharyngolaryngeal region and at least six months have passed since treatment. Patients with dysphagia that is presumed to be caused by chemoradiotherapy. Patients who can provide written informed consent to participate in this study. Patients aged 18 years or older at the time of consent.
Exclusion criteria
Exclusion criteria: Patients suspected of recurrence or metastasis of the primary disease. Patients requiring treatment for the primary disease. Patients with a tracheostomy. Patients with dysphagia presumed to be caused by factors other than chemoradiotherapy. Patients with a pacemaker or an implantable cardioverter-defibrillator. Patients for whom electrode placement on the neck is expected to be difficult. Patients who are expected to have difficulty using medical devices at home safely, from the perspective of cognitive and physical function. Pregnant, possibly pregnant, or breastfeeding patients. Patients deemed inappropriate by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laryngeal Elevation Delay Time in Videofluoroscopic Swallowing Study Video Analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Cases with objectively poor adherence, defined as device usage below 50%, are compared to LEDT in Per Protocol Set cases. Investigation into the causes of discontinuation or suspension during sensory stimulation therapy. VFSS Video Analysis Measurements Laryngeal Elevation Duration, Swallowing Movement Duration, Hyoid Bone Displacement Distance, Hyoid Bone Movement Velocity, Pharyngeal Cavity Area Feasibility of Home-Based Sensory Stimulation Therapy Number of days implemented, Output intensity used, Usage time per session, Duration of therapy continuation Pharyngolaryngeal Sensation Assessment Fiberoptic Endoscopic Evaluation of Swallowing Sensory evaluation using the Hyodo Score, Pharyngolaryngeal Sensory Stimulation Test: 10-point evaluation using the Citric Acid Test Tongue Pressure Measurement Multi-Channel Surface Electromyography QOL Self-Assessment Questionnaires | — |
Contacts
Public ContactTakao Hamamoto
Hiroshima University Hospital
Outcome results
None listed