Protection From Cisplatin Ototoxicity by Lactated Ringers
|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.|
|ClinicalTrials.gov Identifier: NCT00584155|
Recruitment Status : Withdrawn (PI left the university.)
First Posted : January 2, 2008
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Drug: Normal Saline and 0.3% ofloxacin Drug: Lactated Ringer's with 0.03% Ofloxacin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Placebo Comparator: 1
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
Drug: Normal Saline and 0.3% ofloxacin
The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear and are only to be used in the designated ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
Drug: Lactated Ringer's with 0.03% Ofloxacin
The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
- Pre-treatment audiogram will be compared with the post treatment audiogram. The differences between the two will be calculated and compared to the differences in the opposite ear. [ Time Frame: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy ]
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): NCT00584155
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Wayne Berryhill, MD||University of Oklahoma|