Oral mucositis
Conditions
Interventions
Oral care (3 cycles: 63 days) Rebamipide (3 cycles: 63 days)
Oral care (3 cycles: 63 days)
Sponsors
Cinderella Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed histopatholoogically as invasive breast cancer by needle biopsy 2)Patients who will be administrated with FEC100 or TC chemotherapy with cycles >= 3 3)Not permitted the prior treatments such as chemotherapy, molecular targeted therapy, radiotherapy, and immunotherapy, excluding preoperative hormonal therapy 4)Patient who is normal in status of oral mucosa (grade 0) 5)Patient who doesn't have dental caries that needs treatment to exclude influence on oral mucositis 6)Patient who doesn't have incompatible artificial tooth 7) Patient who is not taking medicines* from which influence on oral mucositis is reported within two weeks at the time of registration *:Rebamipide, Allopurinol, Camostat Mesilate, Polaprezinc, Pilocarpine Hydrochloride, Cevimeline Hydrochloride Hydrate, NSAID, Irsogladine Maleate, Teprenone, Lafutidine However, use with a temporary a dose of NSAID is enabled 8)Performance status of 0 or 1 9)Aged 20 to 70 years old, women 10)Patient with whom inspection value meets the following requirements at the time of registration i.WBC >= 4000/mm3 or ANC >= 2000/mm3 ii. Hb >= 9.0 g/dL iii. Platelet >= 100,000/mm3 iv. AST/ALT <= 2.5 x ULN v. T-Bil/D-Bil <= ULN vi. Cr <= 1.5 x ULN 11)LVEF more than 55% 12)Normal or without clinical problem in the electrocardiogram 13)Without interstitial pneumonia or pulmonary fibrosis 14)Patients with written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of oral mucositis with grade >=1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNorikazu Masuda
National Hospital Organization Surgery
Outcome results
None listed