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

JRCT ID: jRCTs071200013

Registered date:11/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral cavity and oropharynx tumor
• Date of first enrollment: 08/09/2021
• Target sample size: 102
• Study type: Interventional
• Intervention(s): Administration of RINDERON-V Ointment 0.12% given on 5 times a day right after waking up, after meals and at bedtime.

Outcome(s)

• Primary Outcome: Incident and time from start of radiation therapy to onset of grade 3 oral mucositis

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Soutome Sakiko