N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.
- Registration Number
- NCT04756622
- Lead Sponsor
- moshe yeshurun
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N acetyl cysteine N acetyl cysteine NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
- Primary Outcome Measures
Name Time Method Proportion of patients with grade 3-4 OM day 14 Proportion of patients with grade 3-4 OM
- Secondary Outcome Measures
Name Time Method Time from transplantation to first hospital discharge 30 days Time from transplantation to first hospital discharge
Proportion of patients with grade 1-4 OM 14 days Proportion of patients with grade 1-4 OM
Non-relapse mortality day 50 Non-relapse mortality