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

• Status: Terminated
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Treatments: Cisplatin; Sodium thiosulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• Karnofsky below 70