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Clinical Trials/NCT01285674
NCT01285674
Unknown
Not Applicable

INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.

Ziv Hospital1 site in 1 country20 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Intra-tympanic Cisplatinum
Conditions
Cisplatin
Sponsor
Ziv Hospital
Enrollment
20
Locations
1
Primary Endpoint
Post-Treatment change in hearing
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ziv Hospital

Eligibility Criteria

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

Arms & Interventions

Intra-tympanic steroid injection

Intervention: Intra-tympanic Cisplatinum

Outcomes

Primary Outcomes

Post-Treatment change in hearing

Time Frame: 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 Outcomes

  • Tinnitus(1 month post-treatment)

Study Sites (1)

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