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

Ototoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01285674
• Other study ID #: 0035-10-ZIV
• Status: Not yet recruiting
• Phase: N/A
• First received: January 23, 2011
• Last updated: January 27, 2011
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2011
• Source: Ziv Hospital
• Contact: Peter Gilbey, MD
• Phone: 972-50-8434014
• Email: peter.g[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Institutional Oversight Authority
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cisplatin
• Intratympanic Steroids
• Ototoxicity

Intervention

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.

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Treatment change in hearing	change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions	approximately 1 month from 1st treatment	No
Secondary	Tinnitus	appearence or worsening of tinnitus as a result of cisplatin treatment	1 month post-treatment	No