Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Apparition of ototoxicity
研究概览
简要总结
The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.
详细描述
This is a monocentric, randomized, controlled, open label phase IV superiority trial.
After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin).
The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18-year-old
- •Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.
排除标准
- •Women of childbearing potential pregnant or with intention to become pregnant within the trial duration
- •Women who are breastfeeding
- •Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.
- •Conductive hearing loss > 20dBHL
- •Meniere disease
- •Medical history of sudden hearing loss
- •Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)
研究组 & 干预措施
N-acetylcysteine
Experimental arm (Arm B):
- 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle.
- Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease)
Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Apparition of ototoxicity
时间窗: 6 month after last injection
the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5: * A Threshold shift of 15 - 25 decibel (dB) averaged at 2 contiguous test frequencies in at least one ear * and/or the apparition of a tinnitus (not previously present).
次要结局
- Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)(6 month after last injection)
- Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA(6 month after last injection)
- Hearing quality of life: Tinnitus Handicap Index (THI)(6 month after last injection)