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

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

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

Study Overview

• Status: Unknown
• Conditions: Ototoxicity; Cisplatin; Intratympanic Steroids
• Intervention / Treatment: Drug: Intra-tympanic Cisplatinum

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Gilbey, MD; Phone Number: 972-50-8434014; Email: peter.g@ziv.health.gov.il

Study Locations

• Israel
  • Safed, Israel, 13100
    • Ziv Medical Center
    • Contact: Peter Gilbey, MD; Phone Number: 972-50-8434014; Email: peter.g@ziv.health.gov.il
    • Principal Investigator: Peter Gilbey, MD
    • Sub-Investigator: Khalil Khalil, MD
    • Sub-Investigator: Jamal Zidan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus	appearence or worsening of tinnitus as a result of cisplatin treatment	1 month post-treatment

Collaborators and Investigators

• Sponsor: Ziv Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2012
• Study Completion (ANTICIPATED): January 1, 2012

Study Registration Dates

• First Submitted: January 23, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (ESTIMATE): January 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 27, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: cisplatin; ototoxicity; intratympanic steroids
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Ototoxicity; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: 0035-10-ZIV