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Sodium Thiosulfate and Mannitol for Cisplatin-Induced Ototoxicity
NCT05129748Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2023
- Primary completion
- Jan 2027
- Countries
- 1
- Sponsor
- Sunnybrook Health Sciences Centre
- Modality
- Inhalation Devices, Small Molecules
- Conditions
- ototoxicity
01
Overview
Phase 2, randomised, open-label trial of sodium thiosulfate and Bronchitol in ototoxicity (2 arms), sponsored by Sunnybrook Health Sciences Centre. Primary endpoint: Improvement in hearing threshold with sodium thiosulfate and mannitol administration at 2 months. Started Feb 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Cisplatin + STS + Mannitol
Standard Cisplatin + Sodium Thiosulfate + Mannitol
Cisplatin Alone
Standard Cisplatin-based Chemotherapy
03
Endpoints
Primary
Improvement in hearing threshold with sodium thiosulfate and mannitol administration
Secondary
Potential oncological impact of sodium thiosulfate and mannitol on long-term renal clearance
Disease Free Survival
Overall Survival
Short and long-term adverse event reporting
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