INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Post-Treatment change in hearing
研究概览
简要总结
In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
详细描述
Cisplatin is a potent and widely used antineoplastic drug. Ototoxicity is a serious and dose-limiting side effect. The ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. There are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. Glucocorticoids have significant potential for otoprotection. Glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, Meniere's disease and sudden sensorineural hearing loss. Intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. This method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. Local administration prevents the common systemic side effects of steroids. Previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. Asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 years old at least who are candidates for Cisplatin treatment
- •agreement to participate in the study
- •have signed an informed consent.
排除标准
- •refusal to participate
- •steroid treatment during the past month
- •external or middle ear disease not enabling intratympanic treatment
- •inner ear disease causing hearing loss
- •severe hearing loss for any reason
- •conductive hearing loss
研究组 & 干预措施
Intra-tympanic steroid injection
干预措施: Intra-tympanic Cisplatinum (Drug)
结局指标
主要结局
Post-Treatment change in hearing
时间窗: approximately 1 month from 1st treatment
change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions
次要结局
- Tinnitus(1 month post-treatment)
