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临床试验/NCT03400709
NCT03400709已完成不适用

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Hospital San Juan de Dios, Santiago1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Hearing threshold

研究概览

简要总结

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.

排除标准

  • Conductive Hearing Loss
  • SNHL with >= 40db PTA

研究组 & 干预措施

N-acetylcisteine group

Experimental

干预措施: N Acetylcysteine (Drug)

Control group

Placebo Comparator

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

Hearing threshold

时间窗: through study completion, an average of 3 months

High frequencies pure tone average

次要结局

未报告次要终点

研究者

发起方
Hospital San Juan de Dios, Santiago
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Munoz MD, MSc.

Otolaryngologist, Clinical Epidemiologist.

Hospital San Juan de Dios, Santiago

研究点 (1)

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