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临床试验/NCT03471416
NCT03471416已完成不适用

Nutritional Status in Children With Acute Lymphoblastic Leukemia (ALL) Undergoing Treatment at the National Pediatric Oncology Unit in Guatemala City, Guatemala

Columbia University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
Association of TSFT and Body Composition

研究概览

简要总结

This study proposes to investigate the association of nutritional status of a children assessed by body mass index (BMI), triceps skinfold thickness (TSFT), and mid upper arm circumference (MUAC), with body composition, measured by dual-energy X-ray absorptiometry (DEXA), in 60 children undergoing treatment of ALL at Unidad Nacional de Oncologia Pediatrica (UNOP), in Guatemala City, Guatemala. The study also aims to establish normative values of body composition in children residing in an LMIC by examining 160 healthy siblings of children under treatment, and to measure habitual physical activity in children with acute lymphoblastic leukemia (ALL) at diagnosis and during therapy.

详细描述

The majority of children with cancer live in low and middle income countries (LMICs) where malnutrition, both under and over nutrition, is highly prevalent. Children who are malnourished while undergoing treatment for acute lymphoblastic leukemia (ALL) are shown to have chances of reduced survival. Children, who are malnourished at diagnosis, if the nutritional status is improved over the course of 6 months during the ALL treatment, have chances of similar survival as the ones who were nourished throughout. Therefore, it is important to study nutritional status in children with ALL, to understand and implement better treatment outcomes. Height and weight alone are considered incomprehensive in classifying nutritional status, especially in poorly nourished children. A more advanced nutritional assessment that distinguishes between fat and muscle mass is required. Treatment for ALL results in an increase in weight over the course of therapy with preferential gain in fat mass (FM) compared to fat free mass (FFM). Hence, there is a pressing need to advance nutritional assessment and implementation in pediatric oncology that includes monitoring of FM and FFM.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children under treatment for Acute Lymphoblastic Leukemia (ALL)
  • Age under 18 years
  • Getting treatment at UNOP

排除标准

  • If they can't participate in the study due to illness or long distance to travel to UNOP

结局指标

主要结局

Association of TSFT and Body Composition

时间窗: Up to 6 months after treatment

Body composition will be measured by DEXA.

Association of MUAC and Body Composition

时间窗: Up to 6 months after treatment

Body composition will be measured by DEXA.

Association of BMI and Body Composition

时间窗: Up to 6 months after treatment

Body composition will be measured by DEXA.

次要结局

  • Body Composition(Up to 6 months after treatment)
  • Habitual Activity Estimation Scale(Up to 6 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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