Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Audiogram
研究概览
简要总结
Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss, tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear structures by reactive oxygen species. Previous animal studies demonstrated that transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect against cisplatin. The purpose of this study is to determine if transtympanic administration of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be measured and statistically analysed for significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 14
- •Patients undergoing platinum based chemotherapy
- •Patients who agree to participate in the study
排除标准
- •Patients unable to provide consent
- •Patients with head and neck cancer
- •Patients undergoing radiation of the head and neck
- •Patients who develop a tympanic perforation
- •Patients with persistent otorrhea
研究组 & 干预措施
Ringer's Lactate
Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.
干预措施: Ringer's Lactate (0.03% Ciprofloxacin) (Drug)
结局指标
主要结局
Audiogram
时间窗: Before and after chemotherapy treatment
Pre-, mid-(if available) and post-chemotherapy treatment audiograms will be compared to determine changes in hearing from baseline and between ears. Hearing will also be assessed every six months after chemotherapy treatment for up to four years to determine possible long-term effects.
次要结局
- Otoacoustic Emissions(Before and after chemotherapy treatment)