Intratympanic injection of N-acetylcysteine for prevention of Cisplatine-induced ototoxicity

CHU Saint Pierre0 个研究点目标入组 86 人开始时间: 2019年11月25日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•- = 18-year-old
•- Patients suffering from a neoplasic disease for which treatment protocol includes Cisplatin.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 52
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•- Women of childbearing potential pregnant or with intention to become pregnant within the trial duration
•NOTE: Women of childbearing potential should use adequate birth control measures, as defined by the investigator. A highly effective method of birth
•control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
•- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
•- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
•- Intrauterine device (IUD)
•- Intrauterine hormone-releasing system (IUS)
•- Bilateral tubal occlusion
•- Vasectomized partner
•- Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
•- Women who are breastfeeding
•- Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing.
•- Conductive hearing loss > 20dBHL
•- Meniere disease
•- Medical history of sudden hearing loss
•- Sensoryneural Hearing loss (SNHL) with mean = 40dbHL Pure Tonal Audiometry (PTA)

发起方

CHU Saint Pierre