LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Neutropenia
研究概览
简要总结
LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.
详细描述
The LEO trial was designed to assess the benefit of administering LifeMel, a honey from bees obtained using Zuf Globus Ltd technology, produced in Israel and listed by the Ministry of Health in Italy as a food supplement. This study aims to highlight a possible role of Lifemel in preventing neutropenic events, as well as reducing anaemia and thrombocytopenia following the administration of chemotherapy in patients with a histological or clinical diagnosis of solid neoplasia undergoing first-line chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •age >=18 years old
- •histological or clinical diagnosis of solid neoplasia
- •indication for chemotherapy treatment with regimens at moderate risk of neutropenia fever - duration of chemotherapy treatment more than 3 months
排除标准
- •known intolerances to honey containing compounds
- •decompensated diabetes or severe glucose intolerance
- •diseases or therapies significantly affecting the neutrophil count
- •concurrent use of G-CSF as primary or secondary prophylaxis in the study
结局指标
主要结局
Neutropenia
时间窗: Three months for each patient
Neutrophil count has been measured the same day or the day before starting every chemotherapy cycle and at expected nadir (between the 7th and 12th day after chemotherapy) in the first 3 months. A patient was considered 'responder' if no episodes of neutropenia was observed during first 3 months of chemotherapy.
次要结局
未报告次要终点