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

NCT07364747 | Recruiting Phase 2 DMC

• 1 other identifier: COA no. SI 655/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cisplatin-induced Ototoxicity; Sensorineural Hearing Loss; Ototoxicity

Outcome Measures

Primary Outcomes (1)

• - Extended high frequency audiogram - DPOAE

  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 Outcomes (2)

• - Extended high frequency audiogram - DPOAE

  Prior to each cisplatin cycle administration and 4 months after completion of treatment

• The subsequent otologic symptoms following cisplatin therapy

  1 month and 4 month after treatment

Study Arms (2)

N acetylcysteine

EXPERIMENTAL

NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin

Drug: Acetyl cysteine

Control Group

PLACEBO COMPARATOR

Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin

Drug: Normal Saline

Interventions

Normal Saline DRUG

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

Control Group

Acetyl cysteine DRUG

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

N acetylcysteine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkoknoi, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Ototoxicity

Interventions

Acetylcysteine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kanthong Thongyai, Master

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naphassakorn Opasatian, Bachelor

CONTACT

66982469575; maymnoshikal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protective Effect of Acetylcysteine against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)