RecruitingPhase 3NCT07281508

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

Transtympanic Sodium Thiosulfate to Prevent Cisplatin-related Hearing Loss A Randomized Controlled Multicenter Phase III Trial; The SOUND Trial


Sponsor

The Netherlands Cancer Institute

Enrollment

100 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate for people with cisplatin-related hearing loss. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranstympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate

The transtympanic injection gel is composed of the following components: * Sodium Thiosulfate 250mg/mL, 10mL for injection (STS) * BiolevoxTM HA 2,2%, 2mL, pre-filled syringe for intraarticular injection (HYA) * Sterile Phosphate-buffered Sodium Chloride, 500mL (PBS)


Locations(5)

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam

Rotterdam, South Holland, Netherlands

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Stichting Radboud University Medical Center

Nijmegen, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07281508