Efficacy, Safety and Quality of Life of Palifermin on Reducing Oral Mucositis in Patients With Hematopoietic Stem Cell Transplantation, Prospective Double-blind Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 88
- 主要终点
- Duration of severe oral mucositis after stem cell transplantation
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adequate organ function
- •patients who will receive autologous stem cell transplantation
- •patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen
排除标准
- •presence of concomitant malignancy
- •presence of active infection or oral mucositis prior to stem cell transplantation
- •any conditions where the severity of oral mucositis cannot be evaluated
研究组 & 干预措施
Palifermin
The patients belong to this arm will be given palifermin, keratinocyte growth factor, in addition to the conventional supportive care for oral mucositis. Palifermin will be given at a dose of 60 mcg/kg for 3 days before commencement of the preparative regimen and for 3 days after stem cell infusion
干预措施: Palifermin (Drug)
结局指标
主要结局
Duration of severe oral mucositis after stem cell transplantation
时间窗: 5 weeks
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
次要结局
- Requirement of opioid drugs(5 weeks)
- Quality of life during transplant period(5 weeks)
- Average VAS score during severe oral mucositis(5 weeks)
- Cost effectiveness of palifermin during stem cell transplantation(5 weeks)
- Incidence of severe oral mucositis after stem cell transplantation(5 weeks)
- Requirement of opioid drugs during severe oral mucositis(5 weeks)
研究者
Ki-Seong Eom, MD
Associate Professor
The Catholic University of Korea