drugset / Trial / NCT07281508

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

NCT07281508

Phase 3 Recruiting 100 enrolled The Netherlands Cancer Institute
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2025-08-14
Primary completion
2030-03-23
Completion
2030-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Thiosulfate Diagnostic / imaging agent 250 mg/ml Other