Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

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.

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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ringer's Lactate

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

Group Type OTHER

Ringer's Lactate (0.03% Ciprofloxacin)

Intervention Type DRUG

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.

Interventions

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Ringer's Lactate (0.03% Ciprofloxacin)

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.

Intervention Type DRUG

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No