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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSiriraj Hospital

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Acetyl cysteine
  • Normal Saline

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators