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

NCT07364747 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

Summary

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).

Conditions

  • Cisplatin-induced Ototoxicity
  • Sensorineural Hearing Loss
  • Ototoxicity
  • Ototoxicity, Drug-Induced

Interventions

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

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

Sponsors & Collaborators

  • Siriraj Hospital

    lead OTHER

Principal Investigators

  • Kanthong Thongyai, Master · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364747 on ClinicalTrials.gov