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
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Scheduled to receive high-dose cisplatin-based chemotherapy with each dose over 50 mg/m2 and a total planned dose above 200 mg/m2
- May receive concurrent chemotherapy with non-ototoxic agents
- May receive radiation therapy to the skull base if radiation dose stays below ototoxic thresholds
- Receiving antiemetic treatment including Olanzapine or Neurokinin-1 receptor antagonists
- Receiving medical care at Siriraj Hospital
You will not qualify if you...
- Diagnosed with nasopharyngeal carcinoma
- History of head and neck radiation where cochlea dose exceeded 9 Gy or eustachian tube dose exceeded 50 Gy on both sides
- Received N-acetylcysteine within 2 weeks before the study
- Received other ototoxic drugs within 2 weeks before or during the study, such as aminoglycoside antibiotics, vancomycin, loop diuretics, high-dose aspirin, or antimalarials
- Known allergy or hypersensitivity to acetylcysteine
AI-Screening
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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
CONTACT
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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