JPRN-UMIN000016109已完成3 期
Evaluation of Oral Care in preventing Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus: Randomized Controlled Phase III Trial - Oral Care-BC
Oral Care-BC executive committee0 个研究点目标入组 200 人开始时间: 2015年1月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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)Toothless jaw 2)Occurrence of stomatitis within 1 month prior to randomization 3)Chemotherapy used within 1 month prior to randomization 4)Exemestane monotherapy used just before the randomization (this is not met, if this therapy has not been used for over 3 months before randomization) 5) Previous mTOR inhibitor treatment (everolimus, etc.) 6)Interstitial pneumonia or pulmonary fibrosis. 7)Treatment with drugs, which are known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes, within 5 days prior to randomization. The dugs are shown below ; rifabutin, rifampicin, clarithromycin, ketoconazole, voriconazole, ritonavir, telithromycin 8)HBs antigen positive, and HBc antibody and/or HBs antibody positive. 9)HCV infection, or a history of HCV infection. 10)History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation. 11)Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a disease-free period of less than 5 years prior to randomization). 12)HER2 overexpression (Her2/neu, Erb B2), and requirement of trastuzumab (herceptin) treatment. In other words, patients that satisfy any of the below conditions will be excluded. At either the primary lesion or the metastatic lesion: a)Strongly Positive (3+) by HER2 immunohistochemical (IHC) test. b)Positive (+) by FISH (fluorescence in situ hybridization). 13)Brain metastasis that requires intracranial hypertension or emergency irradiation of the brain. 14)Extensive liver metastasis, or lymphangitic lung metastasis with accompanying dyspnea. 15)Pleural effusion, ascites, or pericardial effusion that requires emergency treatment. 16)Active infectious disease. 17)Uncontrolled diabetes mellitus or diabetes currently receiving insulin therapy. 18)Study participation is difficult due to mental illness or psychiatric symptoms. 19)Unable to participate the trial by an investigator's judgment
研究者
相似试验
已完成
3 期
Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCTBreast CancerNCT02376985Comprehensive Support Project for Oncology Research174
已完成
不适用
Study on prevention of severe oral mucositis for head and neck cancer patients with radiotherapyhead and neck cancerJPRN-UMIN000028813agasaki University Hospital10
招募中
4 期
Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwashoral mucositisCancer - Children's - Leukaemia & LymphomaOral and Gastrointestinal - Inflammatory bowel diseaseleukemiaACTRN12614000158662Amanda Christina C. Dujua, MD20
招募中
不适用
Verification of effective oral care in preventing Ventilator-Associated pneumonia in ICU patients -A comparative study of oral care in the practical guide to oral care and conventional oral careDiseases and conditions that have been determined to require the use of a ventilatorJPRN-jRCT1040210134Wakisaka Hiroshi40
已完成
不适用
Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantatioHematological malignancyJPRN-UMIN000012275orth Japan Hematology Study Group72