Protection From Cisplatin Ototoxicity by Lactated Ringers

Hearing Loss Clinical Trial

Official title:

Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00584155
• Other study ID #: Lactated Ringers - Berryhill
• Status: Withdrawn
• Phase: Phase 1
• First received: December 20, 2007
• Last updated: May 26, 2015
• Start date: July 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes