Actively Recruiting
Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
Led by Siriraj Hospital · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential of N-acetylcysteine (NAC) to prevent hearing loss caused by cisplatin chemotherapy, which is an effective cancer treatment often leading to permanent ototoxicity. This randomized, double-blind controlled trial aims to see if NAC can protect patients' hearing, especially at extended high frequencies, by comparing hearing sensitivity changes between those receiving NAC and those receiving a placebo. Participants receiving high-dose cisplatin chemotherapy will be randomly assigned to one of two groups: one group will receive NAC intravenously at a dose of 150 mg/kg in 5% dextrose water about 4 to 6 hours after cisplatin administration, while the control group will receive a normal saline intravenous infusion at the same timing. The study includes scheduled hearing evaluations before chemotherapy and before each cisplatin cycle, with follow-ups at one and four months after treatment completion to assess hearing function using audiometry and distortion product otoacoustic emissions (DPOAE). During the study, participants will undergo regular hearing tests to monitor changes in hearing thresholds and cochlear function. Researchers will measure hearing at various frequencies and track otologic symptoms following cisplatin therapy. The primary outcome is the change in hearing at one month after treatment completion. Safety and hearing status will be evaluated throughout, with the total study period extending to several months after chemotherapy to assess longer-term effects.
CONDITIONS
Brief Title
Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 70 years
- Patients scheduled to receive high-dose cisplatin-based chemotherapy with a projected cumulative dose over 200 mg/m2 and each dose above 50 mg/m2
- Patients may receive concurrent chemotherapy with non-ototoxic agents
- Patients may receive radiation to the skull base if radiation dose stays below toxic thresholds for ototoxicity
- Patients receiving an antiemetic regimen including Olanzapine or Neurokinin-1 receptor antagonists
- Patients receiving medical treatment at Siriraj Hospital
You will not qualify if you...
- Patients diagnosed with Nasopharyngeal Carcinoma
- Patients with prior head and neck radiation exceeding 9 Gy to cochlea or 50 Gy to eustachian tube on both sides
- Patients who received N-acetylcysteine within 2 weeks before the study
- Patients who received other ototoxic drugs within 2 weeks before or during the study, including aminoglycoside antibiotics, vancomycin, loop diuretics, high-dose aspirin, or antimalarial drugs
- Patients with known allergy or hypersensitivity to acetylcysteine
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of cisplatin chemotherapy cycles
Participants receive cisplatin chemotherapy and are randomly assigned to receive either N-acetylcysteine or placebo after each cisplatin dose to evaluate protective effects against hearing loss.
Visits before each cisplatin cycle for hearing evaluations and NAC or placebo administration
Duration - 4 months after treatment completion
Participants undergo hearing assessments and monitoring of otologic symptoms at 1 month and 4 months after completion of cisplatin treatment.
2 visits (1 month and 4 months post-treatment)
Trial Site Locations
Total: 1 location
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, Thailand, 10700
Actively Recruiting
Research Team
N
Naphassakorn Opasatian, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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