A preliminary study of the effects of episil(r) oral liquid on chemotherapy- and/or radiation-induced oral mucositis
Not Applicable
Recruiting
- Conditions
- Chemotherapy- and/or radiation-induced oral mucositis
- Registration Number
- JPRN-UMIN000030504
- Lead Sponsor
- Osaka University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients have severely injured area not due to oral mucositis 2) Patients who are known or suspected CNS tumor, metastasis or invasion to the CNS 3) Patients have started the rescue medications on Day 1 prior to the application of episil(r). 4) Patients have known allergy to any ingredient in episil(r) 5) Patients who are participating in other clinical trials 6) Female patients who are breast-feeding, pregnancy or planned pregnancy 7) Patients with considerable concern for compliance with the protocol, in the judgment of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the pain intensity in the oral cavity during 2 hours after a single application of episil(r) , assessed by numerical rating scale score
- Secondary Outcome Measures
Name Time Method Feeling of application of episil(r) , use of rescue mediation, and the incidence of adverse events and device deficiencies