Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01108601
Study type	Interventional
Source	McGill University Health Center
Contact	Victoria Akinpelu
Phone	514-412-4400
Email	victoriakinpelu@gmail.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 2008

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