drugset / Trial / NCT04541355

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

NCT04541355

Phase 2 Completed 16 enrolled Hyunseok Kang, MD NRG Oncology · collab
NaSingle-groupOpen-labelSupportive care

Summary

This phase II trial investigates how well sodium thiosulfate works in preventing ototoxicity (hearing loss/damage) in patients with squamous cell cancer of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing a chemoradiation. Sodium thiosulfate is a type of medication used to treat cyanide poisoning and to help lessen the side effects from cisplatin. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. The purpose of this trial is to find out whether it is feasible to give sodium thiosulfate 4 hours after each cisplatin infusion along with standard of care radiation therapy in patients with head and neck cancer. Giving sodium thiosulfate after cisplatin may help decrease the risk of hearing loss.

Timeline

Start
2020-10-14
Primary completion
2023-05-31
Completion
2023-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Thiosulfate Diagnostic / imaging agent Intravenous
Background Cisplatin Other / unclassified Intravenous