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Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01108601
First received: April 1, 2010
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss, tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear structures by reactive oxygen species. Previous animal studies demonstrated that transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect against cisplatin. The purpose of this study is to determine if transtympanic administration of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be measured and statistically analysed for significance.


Condition Intervention Phase
Hearing Loss
 Drug: Ringer's Lactate (0.03% Ciprofloxacin)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Audiogram [ Time Frame: Before and after chemotherapy treatment ] [ Designated as safety issue: No ]
    Pre-, mid-(if available) and post-chemotherapy treatment audiograms will be compared to determine changes in hearing from baseline and between ears. Hearing will also be assessed every six months after chemotherapy treatment for up to four years to determine possible long-term effects.


Secondary Outcome Measures:
  • Otoacoustic Emissions [ Time Frame: Before and after chemotherapy treatment ] [ Designated as safety issue: No ]
    Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance.


Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ringer's Lactate
Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.
 Drug: Ringer's Lactate (0.03% Ciprofloxacin)
For each patient, only one ear will receive the Ringer's Lactate solution. The other ear will act as a control. To ensure adequate delivery of the solution to the middle ear, a small pressure equalizing tube will be inserted under local anesthesia before commencement of chemotherapy treatment. The patient will be instructed to administer four drops of RL solution to the experimental ear twice a day during their chemotherapy treatment.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over the age of 14
  • Patients undergoing platinum based chemotherapy
  • Patients who agree to participate in the study

Exclusion Criteria:

  • Patients unable to provide consent
  • Patients with head and neck cancer
  • Patients undergoing radiation of the head and neck
  • Patients who develop a tympanic perforation
  • Patients with persistent otorrhea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108601

Contacts
Contact: Victoria Akinpelu 514-412-4400 ext 22249 victoriakinpelu@gmail.com

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A1
Contact: Victoria Akinpelu            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Sam J Daniel, MD McGill University Health Center
  More Information

Additional Information:
Protection From Cisplatin Ototoxicity by Lactated Ringers  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Sam Daniel, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01108601     History of Changes
Other Study ID Numbers: GEN-07-033
Study First Received: April 1, 2010
Last Updated: April 20, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Ringer's
lactate
cisplatin
ototoxicity
hearing loss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ciprofloxacin
 Cisplatin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013