Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Compliance of taking the probiotic/placebo
研究概览
简要总结
The aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis.
详细描述
TRIAL DESIGN
This will be a single-centre double-blind randomised-controlled feasibility study.
TRIAL SETTING
This study will take place at Leeds Teaching Hospital Trust (LTHT), Leeds UK. Participants will be approached whilst admitted as inpatients (typically the paediatric haematology oncology wards) and during outpatient clinics.
METHOD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The liquid probiotic/placebo will be blinded by the pharmacy team and LTHT
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis.
排除标准
- •Patients who have already started the course of chemotherapy. Patients receiving radiotherapy or surgery alone. Patients diagnosed with an immunodeficiency (excluding IgA). Patients who have previously taken probiotics within the month prior to commencing the course of chemotherapy.
研究组 & 干预措施
Probiotic
Participants will start the course of liquid probiotic on the first day of their course of chemotherapy. This can be taken orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day
干预措施: Probiotic (Dietary Supplement)
Placebo
Participants will start the course placebo on the first day of their course of chemotherapy. This can be taken orally or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day
Placebo will be delivered in similar, packaging, appearance and taste.
干预措施: Placebo (Other)
结局指标
主要结局
Compliance of taking the probiotic/placebo
时间窗: 6 months
Proportion of participants who are able to complete the 14 day course
Compliance of filling in the paper/web-app diary
时间窗: 6 months
Proportion of participants who are able to fill in and return the diary for 21 days
Cost-benefit evaluation of the study
时间窗: 6 months
Cost-benefit analysis of undertaking the study
Recruitment
时间窗: 6 months
Proportion of eligible participants successfully recruited to the MaCROS study
次要结局
- Comparison of mucositis in both groups(6 months)
- Proportion of participants who develop fever(6)
- Evaluate responsible guardian/participants experience of the MaCROS study(6 months)
- Incidence of mucositis in both groups(6 months)
研究者
Hadeel Hassan
Clinical Research Fellow
University of Leeds