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
The Netherlands Cancer Institute
100 participants
Aug 14, 2025
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
Inclusion Criteria5
- Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2
- Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles
- Able and willing to give written informed consent;
- WHO performance status of 0, 1 or 2;
- Age older than 18 years.
Exclusion Criteria6
- Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).
- Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
- A planned radiation dose of > 30 Gy to the cochlea (8);
- Known hypersensitivity to STS-containing HYA gel formulation;
- Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;
- Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07281508