Actively Recruiting
Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
Led by The Netherlands Cancer Institute · Updated on 2025-12-15
100
Participants Needed
5
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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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Trial Site Locations
Total: 5 locations
1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
2
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
3
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
4
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584CX
Not Yet Recruiting
5
Stichting Radboud University Medical Center
Nijmegen, Netherlands, 6525GA
Not Yet Recruiting
Research Team
D
Daniël Griffioen, MD
CONTACT
J
Jeany Rademaker-Lakhai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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