Protection From Cisplatin Ototoxicity by Lactated Ringers

Phase 1

Withdrawn

• Conditions: Hearing Loss
• Interventions: Drug: Normal Saline and 0.3% ofloxacin; Drug: Lactated Ringer's with 0.03% Ofloxacin

• Registration Number: NCT00584155
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Normal Saline and 0.3% ofloxacin	Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
2	Lactated Ringer's with 0.03% Ofloxacin	Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States