Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Phase 1

• Conditions: Hearing Loss
• Interventions: Drug: Ringer's Lactate (0.03% Ciprofloxacin)

• Registration Number: NCT01108601
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2010-04
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-20
• Last Update Submitted: 2010-04-20
• Study First Posted: 2010-04-22
• Last Update Posted: 2010-04-22
• Primary Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ringer's Lactate	Ringer's Lactate (0.03% Ciprofloxacin)	Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.

Primary Outcome Measures

Name	Time	Method
Audiogram	Before and after chemotherapy treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada