Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Ciprofloxacin; Cisplatin

Criteria

Inclusion Criteria:

• Patients over the age of 14

• Patients undergoing platinum based chemotherapy

• Patients who agree to participate in the study

Exclusion Criteria:

• 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