Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Days with fever. Fever
研究概览
简要总结
The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
详细描述
Acute lymphoblastic leukaemia (ALL) is the most common form of childhood cancers. Cure rates are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of treatment related complications, mostly related to therapy-induced toxicity and immune suppression. The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. The study is based on patients treated according to the current NOPHO protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization was computer based in blocks of eight to ensure an equal number of participants in each randomization group. The randomization scheme was generated by using the web site Randomization.com ⟨http://www.randomization.com⟩. The randomization center was located at the same hospital as one of the recruitment sites (OUH). The randomization list was sent directly and exclusively to the research secretariat in charge of treatment allocation. Bovine colostrum or the placebo supplement was provided in identical foil sachets differing only in randomization code. Participants, their treating physicians, and any individual involved in the coordination and implementation of the trial were masked to treatment allocation.
入排标准
- 年龄范围
- 1 Year 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol
排除标准
- •Milk Allergy
- •Lactose intolerance
结局指标
主要结局
Days with fever. Fever
时间窗: Measured two times daily and on suspicion during the intervention period, up to four weeks,
Days with temperature at or above 38.5 degrees celsius.
次要结局
- Number of blood and platelet transfusions given during the course of treatment(During the 4 week intervention period.)
- Days in intensive care unit(During the 4 week intervention period)
- Proven or suspected infections(During the 4 week intervention period)
- Serologic markers for systemic inflammation(Weekly and at day 3 and 24, up to 4 weeks.)
- Days in i.v. antibiotic treatment.(During the 4 week intervention period.)
- Duration of cytopenia (neutrocytes <1,0 and platelets <20)(During the 4 week intervention period.)
- Clinical and paraclinical indices of gastrointestinal toxicity(At base line and weekly during the 4 week intervention period. Up to 4 weeks.)
研究者
Steffen Husby
Professor
Odense University Hospital