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RECRUITING
NCT07281508
PHASE3

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-08-14

Completion Date

2030-03-23

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

Transtympanic 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