Clinical Trial

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

Study acronym: SOUND
Recruiting Phase 3
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Summary
The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. The main question it aims to answer is: Researchers will compare the ear treated with STS gel to the untreated ear within the same patient to see if STS prevents hearing loss. Participants will: 1. Receive STS gel injections into the middle ear of one ear (randomized) within 3 hours before each cisplatin infusion (3-7 injections per patient). 2. Undergo hearing tests at baseline and 2-4 months after the last cisplatin treatment. 3. Complete questionnaires about hearing and tinnitus at baseline and 2-4 months after treatment.
Trial Details
NCT Number NCT07281508
Lead Sponsor The Netherlands Cancer Institute
Conditions Cisplatin-related Hearing Loss
Enrollment 100 participants
Start Date 2025-08-14
Primary Completion 2030-03-23 (estimated)
Study Completion 2030-03-23 (estimated)
Updated on ClinicalTrials.gov 2025-12-15