Prevention of severe oral mucositis by RINDERON-V Ointment 0.12% during radiotherapy for oral cavity and oropharynx tumor
Phase 2
Recruiting
- Conditions
- Oral cavity and oropharynx tumorOral cavity and oropharynx tumor, oral mucositis
- Registration Number
- JPRN-jRCTs071200013
- Lead Sponsor
- Soutome Sakiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incident and time from start of radiation therapy to onset of grade 3 oral mucositis
- Secondary Outcome Measures
Name Time Method 1. Incident and time from start of radiation therapy to onset of grade 2 oral mucositis<br>2. Incident and time from start of radiation therapy to onset of oral candidiasis<br>3. treatment completion<br>4. adverse events