Chemotherapy- and/or radiation-induced oral mucositis
Conditions
Interventions
Sponsors
Osaka University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged > 20 years of age at the date of obtaining informed consent 2) Patients who are suffering from oral mucositis due to chemotherapy and/or radiotherapy or conditioning regimens prior to a hematopoietic stem cell transplantation 3) Patients who are suffering from pain; caused by oral mucositis, at a maximum of continued pain and spike pain inside the oral cavity, assessed by Universal Pain Assessment Tool results in at least 5 of Likert scale (0~10) at the start of application of episil(r). 4) Patients at good performance status; eg., at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Feeling of application of episil(r) , use of rescue mediation, and the incidence of adverse events and device deficiencies | — |
Countries
Japan
Contacts
Public ContactShin-ichiro Hiraoka
Osaka University Dental Hospital 1st Department of Oral and Maxillofacial Surgery
Outcome results
None listed