Nutritional Status in Children With ALL in Guatemala

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nutritional Status in Children With Acute Lymphoblastic Leukemia Undergoing Treatment at the National Pediatric Oncology Unit in Guatemala City, Guatemala

Conditions
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Acute Lymphoblastic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children under treatment for Acute Lymphoblastic Leukemia (ALL) Age under 18 years Getting treatment at UNOP Exclusion Criteria: If they can't participate in the study due to illness or long distance to travel to UNOP

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with ALL<br>Children undergoing ALL treatment at UNOP Guatemala who are under the age of 18 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of BMI and Body Composition | Body composition will be measured by DEXA. | Up to 6 months after treatment | 
| Association of TSFT and Body Composition | Body composition will be measured by DEXA. | Up to 6 months after treatment | 
| Association of MUAC and Body Composition | Body composition will be measured by DEXA. | Up to 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Aim to establish normative values of body composition (measured by DEXA) in children residing in an LMIC by examine healthy siblings of children under treatment at UNOP. | Up to 6 months after treatment | 
| Habitual Activity Estimation Scale | Percentage of time awake will be documented in each of 4 activity categories: inactive (lying down), somewhat inactive (SI, sitting down), somewhat active (SA, walking) and very active (VA, those activities that make subject breathe hard and sweat). The use of wake-up and bedtimes as well as meal times and durations allow the calculation of the total number of hours per day spent in each of the 4 categories. Total activity (TA) is calculated as SA+VA for each day. | Up to 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guatemala, Guatemala City, Malnutrition, Leukemia, Childhood Cancer