Protection From Cisplatin Ototoxicity by Lactated Ringers

Sponsor

University of Oklahoma (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00584155

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Drug: Normal Saline and 0.3% ofloxacin Drug: Lactated Ringer's with 0.03% Ofloxacin	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.	Drug: 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.
Experimental: 2 Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.	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.

Arm

Intervention/Treatment

Placebo Comparator: 1

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

Drug: 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.

Experimental: 2

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

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.

Outcome Measures

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. [Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy]