Back to resultsProtection From Cisplatin Ototoxicity by Lactated Ringers
Primary Purpose
Hearing Loss
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Normal Saline and 0.3% ofloxacin
Lactated Ringer's with 0.03% Ofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cisplatin Ototoxicity, Lactated Ringer's, Ear Cancer, Hearing loss, Hearing loss due to Cisplatin Ototoxicity
Eligibility 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
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00584155
Brief Title
Protection From Cisplatin Ototoxicity by Lactated Ringers
Official Title
Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Why Stopped
PI left the university.
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cisplatin Ototoxicity, Lactated Ringer's, Ear Cancer, Hearing loss, Hearing loss due to Cisplatin Ototoxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
Arm Title
2
Arm Type
Experimental
Arm Description
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
Intervention Type
Drug
Intervention Name(s)
Normal Saline and 0.3% ofloxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's with 0.03% Ofloxacin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Berryhill, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Protection From Cisplatin Ototoxicity by Lactated Ringers
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