drugset / Trial / NCT04756622

N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

NCT04756622

Phase 3 Unknown 116 enrolled moshe yeshurun
RandomizedParallel-groupOpen-labelPrevention

Summary

Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.

Timeline

Start
2021-04-01
Primary completion
2022-12-31
Completion
2023-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 600 mg