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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01285674
First received: January 23, 2011
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention
Cisplatin
Ototoxicity
Intratympanic Steroids
 Drug: Intra-tympanic Cisplatinum

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Post-Treatment change in hearing [ Time Frame: approximately 1 month from 1st treatment ] [ Designated as safety issue: No ]
    change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions


Secondary Outcome Measures:
  • Tinnitus [ Time Frame: 1 month post-treatment ] [ Designated as safety issue: No ]
    appearence or worsening of tinnitus as a result of cisplatin treatment


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285674

Contacts
Contact: Peter Gilbey, MD 972-50-8434014 peter.g@ziv.health.gov.il

Locations
Israel
Ziv Medical Center Recruiting
Safed, Israel, 13100
Contact: Peter Gilbey, MD     972-50-8434014     peter.g@ziv.health.gov.il    
Principal Investigator: Peter Gilbey, MD            
Sub-Investigator: Khalil Khalil, MD            
Sub-Investigator: Jamal Zidan, MD            
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Dr Peter Gilbey, Ziv Medical Center, Safed, Israel
ClinicalTrials.gov Identifier: NCT01285674     History of Changes
Other Study ID Numbers: 0035-10-ZIV
Study First Received: January 23, 2011
Last Updated: January 27, 2011
Health Authority: Israel: Institutional Oversight Authority

Keywords provided by Ziv Hospital:
cisplatin
ototoxicity
intratympanic steroids

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013