Prevention of severe oral mucositis by RINDERON-V Ointment 0.12% during radiotherapy for oral cavity and oropharynx tumor

Multicenter interventional study of preventive effects of RINDERON-V Ointment 0.12% for severe oral mucositis during radiotherapy for oral cavity and oropharynx tumor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071200013

Enrollment

102

Registered

2020-05-11

Start date

2021-09-08

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

Oral cavity and oropharynx tumor Oral cavity and oropharynx tumor, oral mucositis

Interventions

Administration of RINDERON-V Ointment 0.12% given on 5 times a day right after waking up, after meals and at bedtime.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with oral cavity and oropharynx tumor undergoing platinum plus IMRT or cetuximab plus IMRT 2. Conventionally fractionated irradiation with 50Gy or more

Exclusion criteria

Exclusion criteria: 1. Patients with problem in judgement 2. Patients who are allergic to the drugs used 3. Women who are or may be pregnant 4. Oral cavity without the radiation field 5. In the event that the investigator or research investigator determines that participation in this study is not appropriate

Design outcomes

Primary

Measure	Time frame
Incident and time from start of radiation therapy to onset of grade 3 oral mucositis	—

Secondary

Measure	Time frame
1. Incident and time from start of radiation therapy to onset of grade 2 oral mucositis 2. Incident and time from start of radiation therapy to onset of oral candidiasis 3. treatment completion 4. adverse events	—

Contacts

Public ContactSakiko Soutome

Nagasaki University Hospital

sakiko@nagasaki-u.ac.jp+81-95-819-7663

Outcome results

None listed

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