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

moshe yeshurun116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

116

Conditions

Mucositis Transplant-Related Disorder

Interventions

N acetyl cysteineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients with grade 3-4 OM

Time frame: day 14

Secondary Outcomes

Proportion of patients with grade 1-4 OM

Time frame: 14 days

Time from transplantation to first hospital discharge

Time frame: 30 days

Non-relapse mortality

Time frame: day 50

Central Contacts

Moshe Yeshurun, MD

CONTACT

0526015543 moshe.yeshurun@gmail.com

Data from ClinicalTrials.gov

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