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Taking peoplePhase 3

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

Key facts

Phase
Phase 3

This trial has no sites in United States.

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

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Trial details

Who runs it
The Netherlands Cancer Institute
Trial code
NCT07281508
Record updated
15 December 2025
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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: 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); 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; Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears); 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.

ClinicalTrials.gov NCT07281508