Clinical Research Directory
Browse clinical research sites, groups, and studies.
Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
Sponsor: The Netherlands Cancer Institute
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
Conditions
Interventions
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