NCT01108601

Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-04-01
• First posted: 2010-04-22
• Last updated: 2010-04-22

Locations

1 site across 1 country: Canada