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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer's Lactate | Other | Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Lactate (0.03% Ciprofloxacin) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Audiogram | 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. | Before and after chemotherapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Otoacoustic Emissions | Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance. | Before and after chemotherapy treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Akinpelu | Contact | 514-412-4400 | 22249 | victoriakinpelu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sam J Daniel, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15547419 | Background | Choe WT, Chinosornvatana N, Chang KW. Prevention of cisplatin ototoxicity using transtympanic N-acetylcysteine and lactate. Otol Neurotol. 2004 Nov;25(6):910-5. doi: 10.1097/00129492-200411000-00009. |
| Label | URL |
|---|---|
| Protection From Cisplatin Ototoxicity by Lactated Ringers | View source |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D000081015 | Ototoxicity |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D024841 |
| Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |