跳至主要内容
临床试验/CTRI/2019/11/022181
CTRI/2019/11/022181尚未招募不适用

Accurate estimation of changes in body composition, energy balance and nutritional status of Indian children with Acute Lymphoblastic Leukaemia (ALL) during cancer treatment

International Atomic Energy Agency1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
68
试验地点
1
主要终点
Novel data providing accurate body composition measurements (BCM and Fat) at baseline along with data on the changes occurring in body composition in children with ALL in India.

研究概览

简要总结

The incidence of paediatric cancer is on the rise with the global prevalence being 14.9 per million. Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer and these children have increased complications during the treatment leading to poor nutritional status and reduced quality of life. The aim of the proposed study is to accurately measure the body composition (body cell mass and fat mass) of children with ALL at diagnosis and during the various stages of chemotherapy & to evaluate the role of diet and physical activity. The findings of the proposed study will provide novel baseline information on the body composition in Indian children with ALL, along with data on the changes occurring in body composition and energy balance during treatment. The data on energy intake and expenditure will provide insights into the possible reasons for energy imbalance.  The proposed study, for the first time will provide data on the composition of fat free mass (FFM) in children with ALL and estimates of the changes in the composition of FFM during treatment in Indian children.  These findings will have clinical relevance in the management of fast mass gain in ALL survivors

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • •Newly detected cases of children with acute lymphoblastic leukaemia Age range 2-8 years Normal healthy children in the age of 2 to 8 as control subjects.

排除标准

  • •Conditions such as diabetes, hormonal problems which could affect body composition Children with sepsis causing hemodynamic compromise and who cannot be assessed.

结局指标

主要结局

Novel data providing accurate body composition measurements (BCM and Fat) at baseline along with data on the changes occurring in body composition in children with ALL in India.

时间窗: End of treatment phase

次要结局

  • Data on the dietary intake, physical activity and energy expenditure of children with ALL which will provide insights into the possible reasons for observed energy imbalance
  • Assessment of frailty in children with ALL during treatment(End of treatment phase)
  • A predictive equation for BCM from simple anthropometric measurements that can be used widely.(End of treatment phase)
  • Estimates of hydration and density of FFM in children with ALL.(End of treatment phase)
  • Information that can be used by professionals to tailor nutritional intervention and ensure the best outcome in oncology patients.(End of treatment phase)

研究者

申办方类型
Other [Intergovernmental forum for scientific and technical co-operation in the nuclear field]

研究点 (1)

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