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

RecruitingPhase 2Ages 18 Years - 70 YearsAllSiriraj Hospital
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Acetyl cysteine
  • Normal Saline
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Where

1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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