ACTRN12618000877280招募中1 期
Phase Ib randomised, placebo-controlled, double-blinded trial using Cimetidine to prevent the Oto-, Nephro- and neuro-toxicity of Cisplatin by OCT2 inhibition in patients undergoing chemoradiation for head and neck cancer
Associate Professor Michael Jameson0 个研究点目标入组 30 人开始时间: 2018年5月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 15 Years 至 o limit（—）
- 性别
- All
入选标准
- •pathologically-confirmed locally-advanced HNSCC for which concurrent chemoradiation using cisplatin 100mg/m2 every 3 weeks for 3 cycles is planned
- •adequate baseline renal function (estimated glomerular filtration rate >60 ml/min)
- •adequate baseline hepatic and bone marrow function;
- •have signed written, informed consent
排除标准
- •planned to receive platinum-based chemotherapy before or after radiation
- •prior chemotherapy with cisplatin or platinum analogues
- •existing hearing loss > 50 dB between 2000 and 8000 Hz, or hearing aids needed
- •radiation treatment plan would result in a cochlear dose > 45 Gy in either ear
- •allergic to cimetidine
- •taking drugs that are substrates of OCT2 (organic cation transporter type 2) unless the medication can safely be omitted on each day of cisplatin and cimetidine administration
- •taking medications with which cimetidine is known to have clinically-significant drug-drug interactions
- •congenital or acquired long QT syndrome
- •co-morbidities that would preclude cisplatin use, such as cardiac failure
- •pregnant or breastfeeding.
研究者
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