Stomatitis
Conditions
Interventions
Oral administration of 2.5 g hangeshashinto three times a day for 8 weeks after onset of stomatitis
Sponsors
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Metastatic or locally recurrent unresectable breast cancer 2) Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer 3) Patients who are scheduled to initiate treatment with everolimus (10mg) once a day 4) ECOG Performance Status of 0-2 5) Postmenopausal 6) Adequate bone marrow, liver and renal function before start of Everolimus administration 7) Baseline absence of oral stomatitis 8) Patients who are expected to survive more than 16 weeks at the time of acquiring consent 9) Asian 10) Age: >= 20 years 11) Capability of oral administration 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have received radiotherapy or chemotherapy 2) Known intolerance or hypersensitivity to everolimus or other rapamycin analogs 3) Known impairment of gastrointestinal (GI) function or GI disease 4) Diabetic patients HbA1c >8%(without patients who have an anamnestic history) 5) Patients who have any uncontrolled medical conditions such as -Unstable angina pectoris, Symptomatic congestive heart failure of New York heart Association Class III or IV, myocardial infarction or any other clinically significant cardiac disease <= 6 months prior to start of Everolimus administration -Active or severe infection -Interstitial pneumonia, pulmonary or fibrosis accompanying dyspnea 6) Patients who received live attenuated vaccines within 1 week of start of Everolimus administration and during the study 7) Patients who have a history of another primary malignancy(Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included) 8) Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain 9) Pleural effusion, ascites, or pericardial effusion that requires emergency treatment 10) Patients who have not had resolution of prior anti-cancer therapy to NCI CTCAE version 4.0 Grade 1 11) Difficulty to participate in this study due to mental illness or psychiatric symptoms 12) Patients who took prohibited medicines or the investigational drug within 4 weeks before enrollment 13) Patients who participated in another study within 4 weeks before enrollment 14) Patients who are pregnancy, possibly pregnancy, considering pregnancy or lactating 15) Patients who are allergic to Kampo medicine 16) Patients who are determined not applicable for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of greater than or equal to grade2(CTCAE ver4.0) stomatitis within 8 weeks after start of Everolimus administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The incidence of each grade stomatitis in 8 weeks after Everolimus administration 2)Rate of Everolimus dose adjustment or discontinuation 3)Adverse event other than stomatitis | — |
Countries
Japan
Contacts
Public ContactYayoi Honda
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital Breast surgery
Outcome results
None listed