Transtympanic sodium thiosulfate to prevent cisplatin-related hearing loss, a randomized controlled multicenter phase III trial; The SOUND trial
- Conditions
- Head and Neck squamous cell carcinomaTherapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method