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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after chemotherapy treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after chemotherapy treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Audiogram

Secondary outcome measures

Otoacoustic Emissions

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

442 Previous Clinical Trials

159,154 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you please share what previous research has been done on this topic?

"26 clinical trials are currently underway to investigate this proposed treatment, with 3 of them being Phase 3 studies. Most of the research is taking place in Durham, North carolina; however, there are 50 different locations where these trials are occurring."

Answered by AI

How many individuals are taking lenalidomide as part of this experiment?

"Currently, this clinical trial is not recruiting patients. This study was first posted on 4/1/2008 and contained its most recent edit on 4/20/2010. There are presently 176 studies actively looking for participants with hearing loss and 26 trials for this treatment actively looking for patients."

Answered by AI

What are the chief medical benefits of this therapy?

"This medication is useful in treating uti caused by entercococcus faecalis. Additionally, it can be helpful for patients struggling with abdominal infection, urinary tract infection, and pseudomonas aeruginosa."

Answered by AI

Are people still being asked to participate in this research project?

"Currently, this trial is not enrolling new patients. The study was first posted on April 1st, 2008 and had its most recent update on April 20th, 2010. For individuals looking for other studies, there are 176 trials actively searching for participants with hearing loss and 26 studies for this treatment actively admitting participants."

Answered by AI

Recent research and studies

Otology & NeurotologyJournal

Prevention of Cisplatin Ototoxicity Using Transtympanic N-acetylcysteine and Lactate

Choe, Won-Taek, Nina Chinosornvatana, and Kay W. Chang. 2004. “Prevention of Cisplatin Ototoxicity Using Transtympanic N-acetylcysteine and Lactate”. Otology & Neurotology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00129492-200411000-00009.

clinicaltrials.govStudy

Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

2008. "Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01108601.

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