NCT04080622已完成3 期
A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of severe oral mucositis (grade 3-4)
研究概览
简要总结
Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
- •Signed informed consent.
排除标准
- •Autologous stem cell transplantation for another medical condition than lymphoma or myéloma.
- •Intolerance to selenium.
- •High selenium levels before study.
- •Pregnancy or patients breast-feeding.
研究组 & 干预措施
Placebo
Placebo Comparator
Usual care
干预措施: Placebos (Drug)
Selenium
Active Comparator
Usual care + selenium 300 µg/day (IV infusion)
干预措施: Selenium (Drug)
结局指标
主要结局
Incidence of severe oral mucositis (grade 3-4)
时间窗: 31 months
次要结局
- Number of days with artifical nutrition(31 months)
- Incidence of any grade oral mucositis(31 months)
- Number of days with severe oral mucositis(31 months)
- Incidence of infectious complications(31 months)
- Number of days with opioids(31 months)
- Duration of hospitalization(31 months)
研究者
研究点 (1)
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