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临床试验/TCTR20240520004
TCTR20240520004尚未招募3 期

Efficacy of intratympanic sodium thiosulfate gel injection to preventisplatin-induced ototoxicity: a randomized controlled trial

Faculty of Medicine, Prince of Songkla University0 个研究点目标入组 43 人开始时间: 2024年5月20日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
43

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
20 Years 至 N/A (No limit)(—)
性别
All

入选标准

  • 1. Age 20 years and above
  • 2. Head and neck cancer patients with confirmed histology
  • 3. Plan to receive high dose cisplatin (> 100 mg mg/m2/cycle) treatment as adjuvant, neoadjuvant or palliative chemotherapy

排除标准

  • 1. Nasopharyngeal cancer and others cancer which mass obstructing eustachian tube
  • 2. History of ear disease, head trauma or prior ear surgery
  • 3. Abnormal tympanic membrane or narrow ear canal of any ear
  • 4. Asymmetrical hearing at baseline (definition is the asymmetry between two ears of more than 10 dB at any frequency)
  • 5. Hearing loss at baseline PTA > 55 dB (Moderately severe sensorineural hearing loss)
  • 6. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to the excipients of the study medications (STS, hyaluronic acid)

研究者

发起方
Faculty of Medicine, Prince of Songkla University

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