Injection of N-acetylcysteine through the eardrum to reduce hearing loss related to Cisplatin chemotherapy.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Ototoxicity; MedDRA version: 20.0Level: PTClassification code 10033109Term: OtotoxicitySystem Organ Class: 10013993 - Ear and labyrinth disorders

• Registration Number: EUCTR2019-004463-44-BE
• Lead Sponsor: CHU Saint Pierre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

- = 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

Exclusion Criteria

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified