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.
试验速览
- 阶段
- 3 期
- 入组人数
- 116
- 主要终点
- Proportion of patients with grade 3-4 OM
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma and lymphoma in partial response and complete remission.
- •Undergoing high-dose chemotherapy with autologous transplantation.
排除标准
- •Known sensitivity to NAC
研究组 & 干预措施
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.
干预措施: N acetyl cysteine (Drug)
结局指标
主要结局
Proportion of patients with grade 3-4 OM
时间窗: day 14
Proportion of patients with grade 3-4 OM
次要结局
- Time from transplantation to first hospital discharge(30 days)
- Proportion of patients with grade 1-4 OM(14 days)
- Non-relapse mortality(day 50)
研究者
moshe yeshurun
Head Bone Marrow UNit
Rabin Medical Center