CTIS2023-503313-30-01进行中（未招募）1 期
Transtympanic sodium thiosulfate to prevent cisplatin-related hearing loss, a randomized controlled multicenter phase III trial; The SOUND trial
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis0 个研究点目标入组 100 人开始时间: 2023年7月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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已完成
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