Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients (Phase II)
Phase 2
- Conditions
- Oral mucositis
- Registration Number
- JPRN-UMIN000005712
- Lead Sponsor
- Cinderella Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patient with impossible oral ingestion of medicine 2)Patients with allergy history for rebamipide 3)Patient with breast cancer relapse or metastasis 4)Women during pregnancy, and women who has likelihood of pregnancy or the intention or breast-feeding 5)Patient who judged that doctor is improper excluding the above-mentioned
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of oral mucositis with grade >=1
- Secondary Outcome Measures
Name Time Method 1)Incidence rate of oral mucositis with grade >=2 2)Incidence rate of oral mucositis with grade >=3 3)Maximum grade of oral mucositis during chemotherapy cycle1-3 4)Safety