Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial

Ki vehet részt

• 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

Ki nem vehet részt

• 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)
• 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
• Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
• 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