Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

January 16, 2026 updated by: Naphassakorn Opasatian, Siriraj Hospital
The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized, double-blind, controlled] trial to investigate the protective effects of N-acetylcysteine (NAC) against cisplatin-induced hearing loss.

Patients scheduled to receive cisplatin chemotherapy will be enrolled. The primary objective is to compare the changes in hearing thresholds between the intervention group (receiving NAC) and the control group. Hearing function will be comprehensively evaluated using:

Pure-tone Audiometry (including Extended High-Frequency Audiometry).

Distortion Product Otoacoustic Emissions (DPOAE) to assess outer hair cell function.

Evaluations will be conducted at baseline (before chemotherapy) and before every cycle of cisplatin administration and 1 month and 4 month after completion . Statistical analysis will include descriptive statistics and comparative tests (such as Unpaired T-tests or Generalized Estimating Equations) to determine the significance of hearing threshold shifts. The study aims to provide evidence on the feasibility and effectiveness of NAC in preserving auditory function in cancer patients.

Outcome Measures

Primary Outcome Measure:

- Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, at one month after the completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE

Secondary Outcome Measure:

  • Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, prior to each cisplatin cycle administration and 4 months after completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
  • The subsequent otologic symptoms following cisplatin therapy

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Bangkoknoi
      • Bangkok, Bangkoknoi, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 18 and 70 years
  • Patients scheduled to receive high-dose cisplatin-based chemotherapy regimens with a projected cumulative cisplatin dose of > 200 mg/m2 and each dose > 50 mg/m2
  • Patients may receive concurrent chemotherapy with non-ototoxic agents
  • Patients may receive concurrent radiation therapy to the skull base, provided the radiation dose does not exceed the toxic threshold for ototoxicity
  • Patients receiving an appropriate antiemetic regimen consisting of Olanzapine or Neurokinin-1 (NK1) receptor antagonists
  • Patients receiving medical treatment at Siriraj Hospital.

Exclusion Criteria:

  • Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx).
  • Patients with a history of head and neck radiation therapy where the radiation dose to the cochlea exceeded 9 Gy or the dose to the eustachian tube exceeded 50 Gy on both sides.
  • Patients who have received N-acetylcysteine (NAC) within 2 weeks prior to the start of the study.
  • Patients who have received other ototoxic drugs within 2 weeks prior to or during the study, including but not limited to:

Aminoglycoside antibiotics, Vancomycin, Loop diuretics (e.g., Furosemide), High-dose Aspirin, Antimalarial drugs (e.g., Quinine)

- Patient with a known allergy or hypersensitivity to acetylcysteine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N acetylcysteine
NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin
Drug: Acetyl cysteine
N-acetylcysteine at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin which dosage more than 50 mg/m2 and planned cumulative dose more than 200 mg/m2
Placebo Comparator: Control Group
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin
Drug: Normal Saline
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin which dosage more than 50 mg/m2 and planned cumulative dose more than 200 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Extended high frequency audiogram - DPOAE
Time Frame: 1 month after completion of cisplatin therapy
Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, at one month after the completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
1 month after completion of cisplatin therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Extended high frequency audiogram - DPOAE
Time Frame: Prior to each cisplatin cycle administration and 4 months after completion of treatment
- Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, prior to each cisplatin cycle administration and 4 months after completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
Prior to each cisplatin cycle administration and 4 months after completion of treatment
The subsequent otologic symptoms following cisplatin therapy
Time Frame: 1 month and 4 month after treatment
The subsequent otologic symptoms following cisplatin therapy
1 month and 4 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Kanthong Thongyai, Master, Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA no. SI 655/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to ensure the protection of participant privacy and to comply with the current institutional ethics committee guidelines

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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