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

Mucositis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04756622
• Other study ID #: 1078-20
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2021
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 0526015543
• Email: moshe.yeshurun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with multiple myeloma and lymphoma in partial response and complete remission.
• Undergoing high-dose chemotherapy with autologous transplantation.

Exclusion Criteria:

• Known sensitivity to NAC

Related Conditions & MeSH terms

• Mucositis
• Stomatitis
• Transplant-Related Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
moshe yeshurun

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with grade 3-4 OM	Proportion of patients with grade 3-4 OM	day 14
Secondary	Proportion of patients with grade 1-4 OM	Proportion of patients with grade 1-4 OM	14 days
Secondary	Time from transplantation to first hospital discharge	Time from transplantation to first hospital discharge	30 days
Secondary	Non-relapse mortality	Non-relapse mortality	day 50