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Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity
NCT07364747Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Siriraj Hospital
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- ototoxicity
01
Overview
Phase 2, randomised, double-blind trial of acetylcysteine in ototoxicity (2 arms), sponsored by Siriraj Hospital. Primary endpoint: Hearing levels by audiometry and DPOAE. Started Dec 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
N acetylcysteine
NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin
Control Group
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin
03
Who it enrols
Adult cancer patients scheduled for high-dose cisplatin chemotherapy, excluding those with nasopharyngeal carcinoma, prior high-dose head/neck radiation, or recent use of ototoxic drugs or NAC.
04
Endpoints
Primary
Hearing levels by audiometry and DPOAE
Secondary
Hearing levels by audiometry and DPOAE
Subsequent otologic symptoms following cisplatin therapy
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