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Transtympanic sodium thiosulfate to prevent cisplatin-related hearing loss, a randomized controlled multicenter phase III trial; The SOUND trial
EU CTIS ID: 2023-503313-30-01
What this study is testing
To assess the efficacy (i.e. clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 likely can't join if
- Asymmetric hearing capacity (SNHL) prior to treatment, defined as an difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies, ≥ 15 dB averaged over 2 adjacent frequencies and ≥ 20 dB at any one frequency in the range of 500-14 kHz, according to the NOAH-4 criteria (43)
- Baseline hearing: more than 40 dB sensorineural hearing loss at PTA 1-2-4 kHz (in one or both ears)
- A planned radiation dose of > 30 Gy to the cochlea (4)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.