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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285674
First Posted: January 28, 2011
Last Update Posted: January 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ziv Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Tinnitus [ Time Frame: 1 month post-treatment ]
    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

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Peter Gilbey, Ziv Medical Center, Safed, Israel
ClinicalTrials.gov Identifier: NCT01285674     History of Changes
Other Study ID Numbers: 0035-10-ZIV
First Submitted: January 23, 2011
First Posted: January 28, 2011
Last Update Posted: January 28, 2011
Last Verified: January 2011

Keywords provided by Ziv Hospital:
cisplatin
ototoxicity
intratympanic steroids

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents