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Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

NCT07281508 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Cisplatin-related Hearing Loss

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)

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Lotje Zuur, Prof. Dr. · AVL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2030-03-23
Completion
2030-03-23

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281508 on ClinicalTrials.gov