Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

NCT01108601 | Unknown Phase 1

• 1 other identifier: GEN-07-033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Ringer's; lactate; cisplatin; ototoxicity; hearing loss

Outcome Measures

Primary Outcomes (1)

• Audiogram

  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.

  Before and after chemotherapy treatment

Secondary Outcomes (1)

• Otoacoustic Emissions

  Before and after chemotherapy treatment

Study Arms (1)

Ringer's Lactate

OTHER

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)

Interventions

Ringer's Lactate (0.03% Ciprofloxacin) DRUG

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.

Ringer's Lactate

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A1, Canada

RECRUITING

Related Publications (1)

• Choe WT, Chinosornvatana N, Chang KW. Prevention of cisplatin ototoxicity using transtympanic N-acetylcysteine and lactate. Otol Neurotol. 2004 Nov;25(6):910-5. doi: 10.1097/00129492-200411000-00009.

  PMID: 15547419 BACKGROUND

Related Links

• Protection From Cisplatin Ototoxicity by Lactated Ringers

MeSH Terms

Conditions

Hearing Loss; Ototoxicity

Interventions

Ringer's Lactate; Ciprofloxacin

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

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

• Sam J Daniel, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Akinpelu

CONTACT

514-412-4400; victoriakinpelu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Last Updated: April 22, 2010

Record last verified: 2010-04

Locations

CA (1)