search
Back to results

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

Primary Purpose

Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral, Ototoxicity

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ototoxic Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Saint-Pierre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

N-acetylcysteine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
Hearing quality of life: Tinnitus Handicap Index (THI)
Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.

Full Information

First Posted
December 9, 2019
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Universitaire Saint Pierre
search

1. Study Identification

Unique Protocol Identification Number
NCT04226456
Brief Title
Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Official Title
Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
September 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral, Ototoxicity, Tinnitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
Lysomucil 10%
Intervention Description
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
Primary Outcome Measure Information:
Title
Apparition of ototoxicity
Description
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).
Time Frame
6 month after last injection
Secondary Outcome Measure Information:
Title
Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)
Description
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).
Time Frame
6 month after last injection
Title
Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA
Description
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.
Time Frame
6 month after last injection
Title
Hearing quality of life: Tinnitus Handicap Index (THI)
Description
Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.
Time Frame
6 month after last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaëtan Cavelier, MD
Organizational Affiliation
Centre Hospitalier Universitaire Saint Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs