Protection From Cisplatin Ototoxicity by Lactated Ringers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.

Conditions
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Hearing Loss

Intervention / Treatment
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* Drug: Normal Saline and 0.3% ofloxacin
* Drug: Lactated Ringer's with 0.03% Ofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Each patient will receive a bottle containing normal saline and 0.03% ofloxacin. | Drug: Normal Saline and 0.3% ofloxacin<br>* 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.<br>|
| Experimental: 2<br>Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin. | Drug: Lactated Ringer's with 0.03% Ofloxacin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisplatin Ototoxicity, Lactated Ringer's, Ear Cancer, Hearing loss, Hearing loss due to Cisplatin Ototoxicity