Study on N-acetylcysteine to Prevent Hearing Loss from Cisplatin Chemotherapy in Adults Aged 18 to 70

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 mgkg 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.

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