Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
Recruiting
Phase 3
Interventional Study
Cisplatin-related Hearing Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 100 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 cispla…
Contacts