A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis
- Conditions
- Chemotherapy- and/or radiation-induced oral mucositis
- Registration Number
- JPRN-UMIN000031921
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Compared to baseline, the mean NRS began to decrease at 5 mins after using Episil ,and this effect lasted up to 120 minutes. The protective effects of Episil were observed already 3 to 5 minutes after application.Some patients felt slight soreness or discomfort when applying Episil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patients have tumor region inside oral cavity 2) Patients have severely injured area not due to oral mucositis 3) Patients who are known or suspected CNS tumor, metastasis or invasion to the CNS 4) Patients have started the rescue medications on Day 1 prior to the application of 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
- Secondary Outcome Measures
Name Time Method