A Phase 2 interventional study of Acetyl cysteine and Normal Saline in Cisplatin-induced Ototoxicity, Sensorineural Hearing Loss and Ototoxicity, sponsored by Siriraj Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Siriraj Hospital · Phase 2, Interventional, and Prevention
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).
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:
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's planned enrollment of 40 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Aminoglycoside antibiotics, Vancomycin, Loop diuretics (e.g., Furosemide), High-dose Aspirin, Antimalarial drugs (e.g., Quinine)
- Patient with a known allergy or to acetylcysteine.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin
Drug: Acetyl cysteine
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin
Drug: Normal Saline
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
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
- 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
Time frame: 1 month after completion of cisplatin therapy
- Extended high frequency audiogram - DPOAE
\- 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
Time frame: Prior to each cisplatin cycle administration and 4 months after completion of treatment
The subsequent otologic symptoms following cisplatin therapy
The subsequent otologic symptoms following cisplatin therapy
Time frame: 1 month and 4 month after treatment
Plan to share: No — Individual participant data will not be shared to ensure the protection of participant privacy and to comply with the current institutional ethics committee guidelines
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
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Studies of the drug tested here: Acetylcysteine
Siriraj Hospital