Effect of Nutritional Intervention Based on Predictive Model of Nutritional Factors on Survival of Adult Umbilical Cord Blood Transplantation Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The thickness of skinfold
研究概览
简要总结
Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.
详细描述
The data of 80 UCBT patients were analyzed retrospectively, and the influence of nutritional parameters on the clinical outcome of UCBT patients was first confirmed, the skinfold thickness ≥20.5 mm and peripheral blood Alb < 33.6 g/L at 30 days after transplantation were the independent influencing factors of OS and DFS. In order to further verify the accuracy of the survival prediction model, the center intends to base on the model and aim at the nutritional parameters of patients 30 days after transplantation, a single-arm, single-center, phase II, prospective intervention trial was conducted to explore individualized nutrition management in UCBT patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old, conscious, with language communication skills;
- •UCBT patients to be performed;
- •Major organs without serious dysfunction;
- •The participants agreed to participate in the study and signed the informed consent form.
排除标准
- •Age < 18 years old or > 65 years old or with cognitive impairment can not complete this survey;
- •Failure or recurrence of transplantation;
- •Combined with severe other organ system diseases (such as severe cardiac insufficiency, autoimmune disease, active infection, severe trauma) ;
- •Patients who have difficulty collecting data to complete the nutritional intervention;
- •Patients who asked to withdraw from the study.
结局指标
主要结局
The thickness of skinfold
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
thickness of skinfold (mm)
Grip strength
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The grip strength (kg)
The body mass index
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Body Mass Index (BMI) is defined as a person's weight in kilograms divided by the square of their height in meters (kg/m²).
Albumin Level
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of Alb (g/L)
The calf circumference
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The calf circumference (cm)
Prealbumin level
时间窗: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of prealbumin (mg/L)
次要结局
- Hospitalization Costs(12 months after transplantation)
- Non-Relapse Mortality (NRM)(12 months after transplantation)
- Overall survival (OS)(12 months after transplantation)
- Disease-free survival (DFS)(12 months after transplantation)
- Incidence of complications(before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.)
- The cumulative incidence of relapse (CIR)(12 months after transplantation)
- Hospitalization Duration(12 months after transplantation)