Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.
Recruitment status was Not yet recruiting
In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
Drug: Intra-tympanic Cisplatinum
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.|
- Post-Treatment change in hearing [ Time Frame: approximately 1 month from 1st treatment ] [ Designated as safety issue: No ]change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions
- Tinnitus [ Time Frame: 1 month post-treatment ] [ Designated as safety issue: No ]appearence or worsening of tinnitus as a result of cisplatin treatment
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Intra-tympanic steroid injection||
Drug: Intra-tympanic Cisplatinum
Intra-tympanic injection (under local anesthesia) of 0.5cc Methylprednisolone 62.5mg/cc. One injection per ear before each of the 3 cisplatin treatments. After injection the patient will remain with the treated ear upwards for 20 minutes and will try to avoid swallowing as much as possible.
Cisplatin is a potent and widely used antineoplastic drug. Ototoxicity is a serious and dose-limiting side effect. The ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. There are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. Glucocorticoids have significant potential for otoprotection. Glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, Meniere's disease and sudden sensorineural hearing loss. Intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. This method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. Local administration prevents the common systemic side effects of steroids. Previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. Asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285674
|Contact: Peter Gilbey, MDfirstname.lastname@example.org|
|Ziv Medical Center||Recruiting|
|Safed, Israel, 13100|
|Contact: Peter Gilbey, MD 972-50-8434014 email@example.com|
|Principal Investigator: Peter Gilbey, MD|
|Sub-Investigator: Khalil Khalil, MD|
|Sub-Investigator: Jamal Zidan, MD|