Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity
Information source: McGill University Health Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hearing Loss
Intervention: Ringer's Lactate (0.03% Ciprofloxacin) (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: McGill University Health Center Official(s) and/or principal investigator(s):
Sam J Daniel, MD, Principal Investigator, Affiliation: McGill University Health Center
Overall contact:
Victoria Akinpelu, Phone: 514-412-4400, Ext: 22249, Email: victoriakinpelu@gmail.com
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.
Clinical Details
Official title: Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Audiogram
Secondary outcome: Otoacoustic Emissions
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Victoria Akinpelu, Phone: 514-412-4400, Ext: 22249, Email: victoriakinpelu@gmail.com
Montreal General Hospital, Montreal, Quebec H3G 1A1, Canada; Recruiting
Victoria Akinpelu
Additional Information
Protection From Cisplatin Ototoxicity by Lactated Ringers
Related publications: Choe WT, Chinosornvatana N, Chang KW. Prevention of cisplatin ototoxicity using transtympanic N-acetylcysteine and lactate. Otol Neurotol. 2004 Nov;25(6):910-5.
Starting date: April 2008
Last updated: April 20, 2010
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