Protection From Cisplatin Ototoxicity by Lactated Ringers - Full Text View

Sponsor:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00584155

Purpose

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	Intervention	Phase
Hearing Loss	Drug: Normal Saline and 0.3% ofloxacin Drug: Lactated Ringer's with 0.03% Ofloxacin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Cancer Hearing Disorders and Deafness

Drug Information available for: Cisplatin Ofloxacin Levofloxacin Ofloxacin hydrochloride Ringer's lactate

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

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. [ Time Frame: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	July 2006
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584155

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator:

Wayne Berryhill, MD

University of Oklahoma

More Information

No publications provided

Responsible Party:	Wayne Berryhill, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00584155 History of Changes
Other Study ID Numbers:	Lactated Ringers - Berryhill
Study First Received:	December 20, 2007
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Oklahoma:

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

Additional relevant MeSH terms:

Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cisplatin
Ofloxacin
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012