Recruiting
Phase 1
Phase 2

Ringer's Lactate

Sponsor:

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

Code:

NCT01108601

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Ringer's Lactate (0.03% Ciprofloxacin)

Study Details

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

Study ID

NCT01108601

Start date

Apr, 2008

Status verified date

Apr, 2010

Primary completion date

Apr, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Ringer's Lactate

Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.

Interventions

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 measure

  • Audiogram [ Time Frame: Before and after chemotherapy treatment ]

Central Contacts and Locations

Central contacts

Victoria Akinpelu

514-412-4400victoriakinpelu@gmail.com

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A1

More Information

Sponsor

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

Last update posted

Apr 22, 2010

Last verified

Apr, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2010-04-22.