Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy
Overview
- Phase
- Phase 1
- Intervention
- Ringer's Lactate (0.03% Ciprofloxacin)
- Conditions
- Hearing Loss
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Audiogram
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Ringer's Lactate
Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.
Intervention: Ringer's Lactate (0.03% Ciprofloxacin)
Outcomes
Primary Outcomes
Audiogram
Time Frame: 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 Outcomes
- Otoacoustic Emissions(Before and after chemotherapy treatment)