Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Hearing Loss Clinical Trial

Official title:

Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01108601
• Other study ID #: GEN-07-033
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 1, 2010
• Last updated: April 20, 2010
• Start date: April 2008

Study information

• Verified date: April 2010
• Source: McGill University Health Center
• Contact: Victoria Akinpelu
• Phone: 514-412-4400
• Email: victoriakinpelu[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Otoacoustic Emissions	Distortion Product Otoacoustic Emissions will also be measured before and after chemotherapy treatment and compared to determine significance.	Before and after chemotherapy treatment	No

External Links

•   Protection From Cisplatin Ototoxicity by Lactated Ringers