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

NCT04226456 | Terminated Phase 4

• 1 other identifier: CHUB-NAC
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ototoxic Hearing Loss; Ototoxic Hearing Loss, Bilateral; Ototoxicity; Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard arm (Arm A): 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.

N-acetylcysteine

EXPERIMENTAL

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.

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteine DRUG

Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears

Also known as: Lysomucil 10%

N-acetylcysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18-year-old
• Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Ototoxicity; Tinnitus

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gaëtan Cavelier, MD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 13, 2020
• Study Start: July 10, 2021
• Primary Completion: May 3, 2023
• Study Completion: September 3, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-02

Locations

BE (1)