Dysgeusia in cancer patients Dysgeusia, Cancer patients, Stochastic Resonance Stimulation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Aged 18 years or older at the time of consent Histologically or clinically diagnosed with cancer Meets at least one of the following conditions Has taste disorder of Grade 1 or higher according to CTCAE v5.0 Native speaker of Japanese Negative for dementia on Mini-Cog screening Able to understand and sign the informed consent form
Exclusion criteria
Exclusion criteria: History of central nervous system disorders such as cerebral infarction, cerebral hemorrhage, or metastatic brain tumors History of surgery, radiation therapy, or chemotherapy for tumors of the tongue or head and neck region Restricted movement of the tongue or jaw Presence of active erosion or ulceration on the tongue Skin lesions at the electrode placement site preventing proper application Implanted pacemaker or defibrillator Presence of severe physical or psychiatric symptoms Hearing impairment requiring the use of a hearing aid in daily life Participation in another clinical trial involving investigational drugs or devices Determined by the investigator to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of decrease in taste recognition threshold before and after stimulation using an electrogustometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS score after stimulation at pre-stimulation recognition thresholds for five basic tastes in the whole-mouth method Proportion of dysgeusia (taste misperception) occurrences PGI-C (Patient Global Impression of Change) scores for each of the five basic tastes using the whole-mouth method Incidence rate of adverse events | — |
Contacts
National Cancer Center Hospital East