JPRN-UMIN000007882招募中3 期
Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy - Comparison of concomitant therapy with 3 drugs, aprepitant + dexamethasone+5HT3ra (palonosetron or granisetron), for prevention of nausea/vomiting in breast cancer patients receiving AC therapy;Trial for Antiemetic Triplet Therapy(TTT)
Juntendo Clinical Research Support Center0 个研究点目标入组 660 人开始时间: 2012年5月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 660
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 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Patients with a history of administration of moderate to high emetogenic chemotherapy 2) Patients receiving administration of an antiemetic drug (5-HT3 receptor antagonist, phenothiazine, butyrophenone, benzamide, or dopamine receptor antagonist) 3) Patients who received administration of a benzodiazepine or narcotic formulation within 48 hours before commencement of AC therapy 4) Patients who received systemic corticosteroid therapy within 72 hours before commencement of AC therapy 5) Patients with a history of gastrointestinal tract surgery (excluding appendectomy) 6) Patients who received or are scheduled to receive radiation therapy for the abdominal region (diaphragm or lower) or pelvis for a period from 6 days before commencement of AC therapy until Day 6 of AC therapy 7) Patients who had vomiting or dry vomiting within 24 hours before commencement of AC therapy 8) Patients with active multiple cancer (synchronous multiple cancer or metachronous multiple cancer with a disease-free interval of 5 years or less) 9) Patients with a symptomatic cerebral tumor (including a benign tumor) 10) Patients who received administration of the following drugs within 7 days before commencement of AC therapy: clarithromycin, erythromycin, ketoconazole, itraconazole, and digoxin 11) Patients who received administration of the following drugs within 4 weeks before commencement of AC therapy: barbiturate drug, rifampicin, phenytoin, and carbamazepine 12) Pregnant or lactating patients, patients who may be pregnant, patients hoping to become pregnant during the study period, and patients taking an oral contraceptive 13) Patients who have coexisting diseases, such as systemic infection, hepatitis, and uncontrollable diabetes, in whom dexamethasone sodium phosphate cannot be administered 14) Patients with a history of hypersensitivity to granisetron, palonosetron, aprepitant or dexamethasone 15) Other patients who are judged to be inappropriate for the study by the investigator.
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