NCT04756622

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

Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: moshe yeshurun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucositis
• Transplant-Related Disorder

Interventions

Type	Name	Description
DRUG	N acetyl cysteine	N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2021-02-16
• Last updated: 2021-02-16