Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.

Not Applicable

• Conditions: Cisplatin; Ototoxicity; Intratympanic Steroids
• Interventions: Drug: Intra-tympanic Cisplatinum

• Registration Number: NCT01285674
• Lead Sponsor: Ziv Hospital

Brief Summary

In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Detailed Description

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-23
• Study First Submitted QC: 2011-01-27
• Last Update Submitted: 2011-01-27
• Study First Posted: 2011-01-28
• Last Update Posted: 2011-01-28
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• adults 18 years old at least who are candidates for Cisplatin treatment
• agreement to participate in the study
• have signed an informed consent.

Exclusion Criteria

• refusal to participate
• steroid treatment during the past month
• external or middle ear disease not enabling intratympanic treatment
• inner ear disease causing hearing loss
• severe hearing loss for any reason
• conductive hearing loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-tympanic steroid injection	Intra-tympanic Cisplatinum	-

Primary Outcome Measures

Name	Time	Method
Post-Treatment change in hearing	approximately 1 month from 1st treatment	change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions

Secondary Outcome Measures

Name	Time	Method
Tinnitus	1 month post-treatment	appearence or worsening of tinnitus as a result of cisplatin treatment

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Safed, Israel