Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
ConditionCisplatin-related Hearing Loss
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
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 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov