Predictors of Malnutrition in Patients With Haematological Cancer
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
- 1
- 主要终点
- Loss of Lean Body Mass
研究概览
简要总结
The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.
详细描述
It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students.
Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used.
Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint.
For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with haematological cancer
- •Patients receiving myelosuppressive chemotherapy for haematological disease
- •Adult patients
排除标准
- •Patients who cannot understand and speak Danish or English
- •Pregnant and breastfeeding
- •Patients who suffer from dementia
结局指标
主要结局
Loss of Lean Body Mass
时间窗: 2 months
Lean Body Mass measured by bioimpedance
次要结局
未报告次要终点
研究者
Jens Rikardt Andersen
Assoc Prof
University of Copenhagen