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Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity

NCT02281006 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-01-27

No results posted yet for this study

Summary

This study evaluates whether a gel containing sodium thiosulfate deposited via a trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity caused by the drug Cisplatin among patients with head and neck cancer treated by chemoradiation. One ear selected randomly will be treated while the other will serve as control.

Conditions

Interventions

DRUG

Trans-tympanic injection of a sodium thiosulfate gel

A sodium thiosulfate hyaluronate gel will be prepared by mixing 0.55 ml of a 25% solution of sodium thiosulfate pentahydrate (Seacalphyx, DIN 02386666, Seaford Pharmaceuticals Inc.) and 0.55 ml of a hyaluronate gel (Healon 10 mg, Abbott Medical Optics Inc.). On the day before each Cisplatin treatment an otologist will deposit 0.1 ml of the gel exactly on the round window of the middle ear.

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Francois Meyer, MD, DSc · CHU de Quebec (Université Laval)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-01-20
Completion
2017-01-20

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281006 on ClinicalTrials.gov