Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
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
- 否
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
干预措施: N Acetylcysteine (Drug)
Control group
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
Daniel Munoz MD, MSc.
Otolaryngologist, Clinical Epidemiologist.
Hospital San Juan de Dios, Santiago
