Status:
TERMINATED
Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
DDP
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Cisplati...
Detailed Description
Background Cisplatin (cis-DiammineDichloridoPlatinum, DDP) is an antineoplastic agent used in the treatment of solid malignant tumors in adults and is also a key part of treatment for many children a...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed locally advanced (stage III or IV) squamous cell carcinoma of the mouth, oropharynx, hypopharynx, or larynx scheduled to be treated with concomitant chemoradiation including Cisplatin100 mg/m2 3 times
- Normal otoscopic findings and symmetrical hearing
Exclusion
- Karnofsky below 70
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02281006
Start Date
January 1 2015
End Date
January 20 2017
Last Update
January 27 2017
Active Locations (1)
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1
CHU de Quebec
Québec, Quebec, Canada, G1R 2J6