Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.
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|ClinicalTrials.gov Identifier: NCT01285674|
Recruitment Status : Unknown
Verified January 2011 by Ziv Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 28, 2011
Last Update Posted : January 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cisplatin Ototoxicity Intratympanic Steroids||Drug: Intra-tympanic Cisplatinum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
|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.
- 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
- Tinnitus [ Time Frame: 1 month post-treatment ]appearence or worsening of tinnitus as a result of cisplatin treatment
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
|Contact: Peter Gilbey, MDfirstname.lastname@example.org|
|Ziv Medical Center||Recruiting|
|Safed, Israel, 13100|
|Contact: Peter Gilbey, MD 972-50-8434014 email@example.com|
|Principal Investigator: Peter Gilbey, MD|
|Sub-Investigator: Khalil Khalil, MD|
|Sub-Investigator: Jamal Zidan, MD|