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Ringer's Lactate Injection for Hearing Loss

Phase 1 & 2
Waitlist Available
Led By Sam J Daniel, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients over the age of 14
Patients undergoing platinum based chemotherapy
Must not have
Patients unable to provide consent
Patients with head and neck cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after chemotherapy treatment
Awards & highlights
Approved for 40 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing whether injecting Ringer's Lactate into the ear via a pressure equalising tube can prevent tinnitus, vestibular dysfunction and hearing loss in patients undergoing platinum based chemotherapy treatment.

Who is the study for?
This trial is for individuals over the age of 14 who are undergoing platinum-based chemotherapy and agree to participate. It excludes those unable to consent, with head and neck cancer, receiving head/neck radiation, having a tympanic perforation or persistent otorrhea.
What is being tested?
The study tests if Ringer's Lactate (with a bit of Ciprofloxacin) injected into the ear can prevent hearing loss caused by cisplatin or carboplatin chemotherapy. Participants will have their hearing tested before and after treatment to see if it helps.
What are the potential side effects?
Potential side effects may include discomfort from the injection process, possible infection risk due to ear tube placement, and rare allergic reactions to components in Ringer's Lactate or Ciprofloxacin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 14 years.
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I am currently receiving platinum-based chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent by myself.
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I have cancer in my head or neck.
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I am receiving radiation therapy for my head or neck.
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I have ongoing ear discharge.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after chemotherapy treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after chemotherapy treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Audiogram
Secondary study objectives
Otoacoustic Emissions

Awards & Highlights

Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ringer's LactateExperimental Treatment1 Intervention
Each patient will act as their own control with one ear receiving treatment, and the contralateral ear acting as control.

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
471 Previous Clinical Trials
166,937 Total Patients Enrolled
Sam J Daniel, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Media Library

Ringer's Lactate Clinical Trial Eligibility Overview. Trial Name: NCT01108601 — Phase 1 & 2
Hearing Loss Research Study Groups: Ringer's Lactate
Hearing Loss Clinical Trial 2023: Ringer's Lactate Highlights & Side Effects. Trial Name: NCT01108601 — Phase 1 & 2
Ringer's Lactate 2023 Treatment Timeline for Medical Study. Trial Name: NCT01108601 — Phase 1 & 2
~1 spots leftby Jan 2026
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