Hearing Loss
Conditions
Keywords
Ringer's, lactate, cisplatin, ototoxicity, hearing loss
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.
Interventions
DRUGRinger'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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audiogram | 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
| Measure | Time frame | Description |
|---|---|---|
| Otoacoustic Emissions | Before and after chemotherapy treatment | Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance. |
Countries
Canada
Contacts
Primary ContactVictoria Akinpelu
Outcome results
None listed