Protection From Cisplatin Ototoxicity by Lactated Ringers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-06-30

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.

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.

Group Type PLACEBO_COMPARATOR

Normal Saline and 0.3% ofloxacin

Intervention Type DRUG

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.

2

Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.

Group Type EXPERIMENTAL

Lactated Ringer's with 0.03% Ofloxacin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No