Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

McGill University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hearing Loss

Treatments: Drug: Ringer's Lactate (0.03% Ciprofloxacin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01108601

GEN-07-033

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ringer's Lactate

Other group

Description:

Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.

Treatment:

Drug: Ringer's Lactate (0.03% Ciprofloxacin)