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Completed

NCT Number: NCT03471416

Nutritional Status in Children With ALL in Guatemala

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Nutrition Disorders Nutritional and Metabolic Diseases Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidad Nacional de Oncología Pediátrica (UNOP)

Guatemala City, Guatemala

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association of BMI and Body Composition

    Time frame: Up to 6 months after treatment

    Body composition will be measured by DEXA.

  2. Association of TSFT and Body Composition

    Time frame: Up to 6 months after treatment

    Body composition will be measured by DEXA.

  3. Association of MUAC and Body Composition

    Time frame: Up to 6 months after treatment

    Body composition will be measured by DEXA.

Secondary outcomes

  1. Body Composition

    Time frame: Up to 6 months after treatment

    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.

  2. Habitual Activity Estimation Scale

    Time frame: Up to 6 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Unidad nacional de Oncologia Pediatrica, Guatemala

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2018
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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