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

Ziv Hospital

Status: Unknown

Conditions: Intratympanic Steroids; Ototoxicity; Cisplatin

Treatments: Drug: Intra-tympanic Cisplatinum

Study type: Interventional

Funder types: Other

Identifiers

NCT01285674

0035-10-ZIV

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intra-tympanic steroid injection

Experimental group

Treatment:

Drug: Intra-tympanic Cisplatinum