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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226456
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ototoxic Hearing Loss Ototoxic Hearing Loss, Bilateral Ototoxicity Tinnitus Drug: N-acetyl cysteine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control

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: N-acetylcysteine

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




Primary Outcome Measures :
  1. Apparition of ototoxicity [ Time Frame: 6 month after last injection ]

    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 :
  1. Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System) [ Time Frame: 6 month after last injection ]

    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).

  2. Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA [ Time Frame: 6 month after last injection ]
    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.

  3. Hearing quality of life: Tinnitus Handicap Index (THI) [ Time Frame: 6 month after last injection ]
    Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing.
  • Conductive hearing loss > 10 decibel hearing level (dBHL)
  • Meniere disease
  • Medical history of sudden hearing loss
  • Sensorineural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226456


Contacts
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Contact: Gaëtan CAVELIER, MD 003225354267 gaetan_cavelier@stpierre-bre.be
Contact: Mihaela Horoi, MD 003225354267 mihaela_horoi@stpierre-bru.be

Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT04226456    
Other Study ID Numbers: CHUB-NAC
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Tinnitus
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes