Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

McGill University Health Centre/Research Institute of the McGill University Health Centre20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

For each patient, only one ear will receive the Ringer's Lactate solution. The other ear will act as a control. To ensure adequate delivery of the solution to the middle ear, a small pressure equalizing tube will be inserted under local anesthesia before commencement of chemotherapy treatment. The patient will be instructed to administer four drops of RL solution to the experimental ear twice a day during their chemotherapy treatment.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Audiogram

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.

Time frame: Before and after chemotherapy treatment

Secondary Outcomes

Otoacoustic Emissions

Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance.