Protection From Cisplatin Ototoxicity by Lactated Ringers
Information source: University of Oklahoma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hearing Loss
Intervention: Normal Saline and 0.3% ofloxacin (Drug); Lactated Ringer's with 0.03% Ofloxacin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s):
Wayne Berryhill, MD, Principal Investigator, Affiliation: University of Oklahoma
Overall contact:
Dini Chissoe, BS, Phone: 405-271-5504, Email: geraldine-chissoe@ouhsc.edu
Summary
The purpose of this study is to determine if Lactated Ringer's solution is effective in
patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to
cisplatin-induced hearing loss.
Clinical Details
Official title: Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with cancer to be treated with cisplatin.
- Patients expected to receive a minimum of 3 rounds of chemotherapy.
- Patients receiving a minimum dose of cisplatin of 70 mg/m2
Exclusion Criteria:
- Patients who have had middle ear surgery.
- Patients who have active external or middle ear disease
- Patients who have preceding pure tone average of >40 dB HL
Locations and Contacts
Dini Chissoe, BS, Phone: 405-271-5504, Email: geraldine-chissoe@ouhsc.edu
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Additional Information
Starting date: July 2006
Ending date: August 2008
Last updated: June 26, 2009
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