drugset / Trial / NCT01108601

Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

NCT01108601

RandomizedSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2008-04
Primary completion
2011-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciprofloxacin Small molecule 0.03 % Other
Subject Ringer's Lactate Other / unclassified Other

Indications