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Nutritional Status in Children With ALL in Guatemala

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03471416
Enrollment
109
Registered
2018-03-20
Start date
2019-05-01
Completion date
2022-09-01
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Guatemala, Guatemala City, Malnutrition, Leukemia, Childhood Cancer

Brief summary

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

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.

Interventions

None listed

Sponsors

Unidad nacional de Oncologia Pediatrica, Guatemala
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Association of BMI and Body CompositionUp to 6 months after treatmentBody composition will be measured by DEXA.
Association of TSFT and Body CompositionUp to 6 months after treatmentBody composition will be measured by DEXA.
Association of MUAC and Body CompositionUp to 6 months after treatmentBody composition will be measured by DEXA.

Secondary

MeasureTime frameDescription
Body CompositionUp to 6 months after treatmentAim 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.
Habitual Activity Estimation ScaleUp to 6 months after treatmentPercentage 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.

Countries

Guatemala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026