Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity
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|ClinicalTrials.gov Identifier: NCT01108601|
Recruitment Status : Unknown
Verified April 2010 by McGill University Health Center.
Recruitment status was: Recruiting
First Posted : April 22, 2010
Last Update Posted : April 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Drug: Ringer's Lactate (0.03% Ciprofloxacin)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2011|
Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.
Drug: Ringer's Lactate (0.03% Ciprofloxacin)
For each patient, only one ear will receive the Ringer's Lactate solution. The other ear will act as a control. To ensure adequate delivery of the solution to the middle ear, a small pressure equalizing tube will be inserted under local anesthesia before commencement of chemotherapy treatment. The patient will be instructed to administer four drops of RL solution to the experimental ear twice a day during their chemotherapy treatment.
- Audiogram [ Time Frame: Before and after chemotherapy treatment ]Pre-, mid-(if available) and post-chemotherapy treatment audiograms will be compared to determine changes in hearing from baseline and between ears. Hearing will also be assessed every six months after chemotherapy treatment for up to four years to determine possible long-term effects.
- Otoacoustic Emissions [ Time Frame: Before and after chemotherapy treatment ]Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance.
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): NCT01108601
|Contact: Victoria Akinpelu||514-412-4400 ext firstname.lastname@example.org|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A1|
|Contact: Victoria Akinpelu|
|Principal Investigator:||Sam J Daniel, MD||McGill University Health Center|