Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

Tinnitus Clinical Trial

Official title:

Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04226456
• Other study ID #: CHUB-NAC
• Status: Terminated
• Phase: Phase 4
• Start date: July 10, 2021
• Est. completion date: September 3, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18-year-old

• Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Ototoxic Hearing Loss
• Ototoxic Hearing Loss, Bilateral
• Ototoxicity
• Tinnitus

Intervention

Drug:
• N-acetyl cysteine
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparition of ototoxicity	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).	6 month after last injection
Secondary	Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)	the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5: A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear; and/or the apparition of a tinnitus (not previously present).	6 month after last injection
Secondary	Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA	Evaluation of the Impact of Hearing Loss in Adults (ERSA) For each question, the score of 0 means maximal difficulties, the sore of 10 means ideal situation Formulation is uniform, with no inversions: 0 always corresponds to maximal difficulty and 10 to an ideal situation, so that the lower the score the greater the impact of hearing loss on quality of life. Maximum score is 200 for respondents in work and 150 for those not in work or in retirement.	6 month after last injection
Secondary	Hearing quality of life: Tinnitus Handicap Index (THI)	Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.	6 month after last injection