Protection From Cisplatin Ototoxicity by Lactated Ringers

NCT00584155 | Withdrawn Phase 1

• 1 other identifier: Lactated Ringers - Berryhill
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Cisplatin Ototoxicity; Lactated Ringer's; Ear Cancer; Hearing loss; Hearing loss due to Cisplatin Ototoxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Normal Saline and 0.3% ofloxacin

2

EXPERIMENTAL

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

Drug: Lactated Ringer's with 0.03% Ofloxacin

Interventions

Normal Saline and 0.3% ofloxacin 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.

1

Lactated Ringer's with 0.03% Ofloxacin 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hearing Loss; Ear Neoplasms

Interventions

Saline Solution; Ofloxacin; Ringer's Lactate

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wayne Berryhill, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: July 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 27, 2015

Record last verified: 2010-06

Locations

US (1)