EUCTR2019-004463-44-BE
Active, not recruiting
Phase 1
Intratympanic injection of N-acetylcysteine for prevention of Cisplatine-induced ototoxicity
CHU Saint Pierre0 sites86 target enrollmentNovember 25, 2019
ConditionsOtotoxicityMedDRA version: 20.0Level: PTClassification code 10033109Term: OtotoxicitySystem Organ Class: 10013993 - Ear and labyrinth disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsLysomucil®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ototoxicity
- Sponsor
- CHU Saint Pierre
- Enrollment
- 86
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Intratympanic Injections of N-acetylcysteine and Dexamethasone for Prevention of Cisplatin-induced Ototoxicity: Double Blind Randomized Clinical Trialhearing impairmentHearing LossIntratympanic InjectionDexamethasoneAcetylcysteineTCTR20160314003Student Research Committee114
Recruiting
Phase 3
Preoperative intranenous N-Acetylcysteine for the prevention of renal failure in patients with renal impairment undergoing cardiac surgeryRenal Impairment in cardiac surgeryRenal and Urogenital - Other renal and urogenital disordersCardiovascular - Other surgeryACTRN12606000088549Prince of Wales Hospital200
Enrolling By Invitation
Phase 3
Intravenous N-acetyl-cysteine (NAC) for Prevention of Post-embolization Syndrome in Hepatocellular CarcinomaHepatocellular CarcinomaTransarterial ChemoembolizationTCTR20150313002Faculty of Medicine, Thammasat University80
Recruiting
Phase 1
Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.Ototoxic Hearing LossNCT04291209Sunnybrook Health Sciences Centre80
Terminated
Phase 4
Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced OtotoxicityOtotoxic Hearing LossOtotoxic Hearing Loss, BilateralOtotoxicityTinnitusNCT04226456Centre Hospitalier Universitaire Saint Pierre19