Xerostomia (Dry Mouth)
Conditions
Interventions
Deep ocean water group: Participants will use a deep ocean water-based mouthwash three times daily, 20 mL per use, for 4 weeks. The mouthwash will be held in the oral cavity for 30 seconds and then ex
data obtained after this post-trial provision will not be included in the primary analysis.
Sponsors
Toyama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are outpatients or inpatients at the Department of Otorhinolaryngology, Head and Neck Surgery, or Internal Medicine of Toyama University Hospital, or the Department of Oral and Maxillofacial Surgery of Toyama City Hospital 2. Adult patients aged 18 years or older 3. Patients with subjective oral dryness and a xerostomia VAS score of 40 mm or higher 4. Patients with an unstimulated salivary flow rate of less than 0.2 mL/min or a Saxon test result of less than 2 g/2 min 5. Patients who are able to comply with the intervention and assessment schedule during the study period 6. Patients who have received an explanation of the purpose and methods of the study and have provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with highly active inflammatory autoimmune diseases, such as Sjogren's syndrome, systemic lupus erythematosus, or rheumatoid arthritis. 2. Patients undergoing intensive chemotherapy who have oral mucositis of Grade 3 or higher according to CTCAE v5.0. 3. Patients with renal failure, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73 m2, or heart failure of NYHA class III or higher. 4. Patients with electrolyte abnormalities, defined as serum sodium less than 135 mEq/L or serum potassium 5.5 mEq/L or higher. 5. Patients with a history of allergy to seafood or mineral components. 6. Pregnant or lactating women. 7. Patients judged by the principal investigator to be inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the xerostomia visual analog scale (VAS) score (0to100 mm) at 4 weeks after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include unstimulated salivary flow, stimulated salivary flow, oral mucositis score based on the modified WHO scale, oral health-related quality of life assessed using the Japanese version of OHIP-14, salivary biomarkers, and the frequency and details of adverse events at 4 and 6 weeks after the start of intervention. Exploratory subgroup analyses will also be performed according to the presence or absence of a history of radiation therapy. | — |
Countries
Japan
Contacts
Public ContactYOSUKE TAJIKA
Toyama University Hospital Laboratory of Anatomic Pathology
Outcome results
None listed