Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Study Overview
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Brief Summary
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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.

Official Title
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Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy

Conditions
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Hearing Loss

Intervention / Treatment
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* Drug: Ringer's Lactate (0.03% Ciprofloxacin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ringer's Lactate<br>Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control. | Drug: Ringer's Lactate (0.03% Ciprofloxacin)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before and after chemotherapy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoacoustic Emissions | Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance. | Before and after chemotherapy treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ringer's, lactate, cisplatin, ototoxicity, hearing loss