Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
About one-third of people who have been given Cisplatin, as part of their chemotherapy
treatment, develop hearing loss. The purpose of this study is to determine if some degree
of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To
study this, patients will use drops in their ears; Lactated Ringer's will be placed in one
ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop
antibiotic will be placed in each ear at the same time. Each participant will receive a
hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after
the final treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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.
Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy
Wayne Berryhill, MD
University of Oklahoma
United States: Food and Drug Administration
Lactated Ringers - Berryhill
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|