CTRI/2021/03/032165进行中（未招募）3 期
Olanzapine versus fosaprepitant for preventionof chemotherapy induced nausea and vomitingin patients receiving carboplatin (AUC=4)containing chemotherapy regimen: ARandomized, double-blind, placebo-controlledtrial ?
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AIIMS
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
入选标准
- •1Patients with pathologically confirmed malignancies
- •2Age =18 years
- •3Chemo-naïve
- •4Scheduled to receive first cycle of carboplatin-based chemotherapy with AUC=4
- •5Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •6Meeting the following standard values of general clinical tests:
- •aANC >1000
- •bAspartate aminotransferase =100U/L.
- •cAlanine aminotransferase =100U/L.
- •dTotal bilirubin =2.0mg/dL.
- •7Written informed consent
排除标准
- •Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy
- •Any history of CNS disease including brain metastasis, seizure disorder or psychosis
- •Active infection or uncontrolled medical condition other than malignancy
- •Need for medication that strongly induces CYP3A4 activity (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)
- •Patients on systemic steroids other than for use as an antiemetic agent
- •Prior aprepitant/fosaprepitant or olanzapine use.
- •Planned to receive quinolone antibiotics while receiving olanzapine.
- •Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducer or inhibitors.
- •Received radiotherapy to abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation
- •Hypersensitivity to olanzapine or fosaprepitant
- •Cardiac arrhythmia, uncontrolled congestive heart failure or acute MI within the previous 6 months.
- •Uncontrolled Diabetes mellitus
- •Pregnant or breast-feeding females or those not willing for contraception.
研究者
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