NCT04698616Unknown不适用
The Relation Between Lean Body Mass and Side Effects Induced by Chemotherapy in Patients With Lymphoma: A Prospective Cohort Study
Jens Rikardt Andersen2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2020年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Lean Body Mass (LBM)
研究概览
简要总结
The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.
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 receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
- •Legal of age
排除标准
- •ECOG Performance Status ≥2
- •People who cannot speak and understand Danish
- •Pregnant and breastfeeding
结局指标
主要结局
Lean Body Mass (LBM)
时间窗: 8 weeks (two treatment cycles)
LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given
次要结局
- Quality of life (QOL) (score EORTC)(8 weeks (two treatment cycles))
- Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM),(8 weeks (two treatment cycles))
- nutritional status at inclusion (NRS2002 - scale)(8 weeks (two treatment cycles))
- physical activity (scale - questionaire)(8 weeks (two treatmenr cycles))
研究者
Jens Rikardt Andersen
Sponsor - Investigator
University of Copenhagen
研究点 (2)
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