Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
- Conditions
- Stomatitis
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method