A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis

A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis - A preliminary study of a new oral mucosa protective material

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031921

Enrollment

Registered

2018-03-30

Start date

2018-03-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy- and/or radiation-induced oral mucositis

Interventions

A single application of episil(R) oral liquid by 3 pump strokes (0.45 mL) to affected area

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. 5) Patients have no allergy to any ingredient in episil(r)

Exclusion criteria

Exclusion criteria: 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

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. Change in the effect on improvement in difficulties in food taking and speaking.	—

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 ContactTakao Ueno

National Cancer Center Hospital Department of Dentistry

taueno@ncc.go.jp+81-3-3547-5201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026