JPRN-UMIN000031196已完成未知
Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer. - Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital0 个研究点目标入组 60 人开始时间: 2018年3月31日最近更新:
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •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
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