Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108601
Recruitment Status : Unknown
Verified April 2010 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : April 22, 2010
Last Update Posted : April 22, 2010
Information provided by:
McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Hearing Loss Drug: Ringer's Lactate (0.03% Ciprofloxacin) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy
Study Start Date : April 2008
Estimated Primary Completion Date : April 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Audiogram [ Time Frame: Before and after chemotherapy treatment ]
    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 :
  1. Otoacoustic Emissions [ Time Frame: Before and after chemotherapy treatment ]
    Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108601

Contact: Victoria Akinpelu 514-412-4400 ext 22249

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

Additional Information:
Responsible Party: Dr. Sam Daniel, McGill University Health Center Identifier: NCT01108601     History of Changes
Other Study ID Numbers: GEN-07-033
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010

Keywords provided by McGill University Health Center:
hearing loss

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors