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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok
Contact Information
Primary
Naphassakorn Opasatian, Bachelor
maymnoshikal@gmail.com
66982469575
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 40
Treatments
Experimental: N acetylcysteine
NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin
Placebo_comparator: Control Group
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin
Related Therapeutic Areas
Sponsors
Leads: Siriraj Hospital

This content was sourced from clinicaltrials.gov

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