Nutritional Status in Children With ALL in Guatemala

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

Study Overview

• Status: Unknown
• Conditions: Acute Lymphoblastic Leukemia

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Suvekshya Aryal, MPH; Phone Number: 646-317-2070; Email: sa3234@cumc.columbia.edu
• Study Contact Backup: Name: Elena J Ladas, RD, PhD; Phone Number: 212.305.7835; Email: ejd14@cumc.columbia.edu

Study Locations

• Guatemala
  • Guatemala City, Guatemala
    • Recruiting
    • Unidad Nacional De Oncologia Pediatrica
    • Contact: Federico Antiloon, MD, MMM, PhD; Email: fantillo@ufm.edu
    • Principal Investigator: Federico Antiloon, MD, MMM, PhD
    • Sub-Investigator: Ana Lucia Molina, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children undergoing ALL treatment at UNOP Guatemala - must be under the age of 18 years. Their healthy siblings will be recruited to compare body composition.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with ALL; Children undergoing ALL treatment at UNOP Guatemala who are under the age of 18 years.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Unidad nacional de Oncologia Pediatrica, Guatemala
• Investigators: Study Chair: Ronald Barr, MB, ChB, MD, McMaster University; Principal Investigator: Federico Antiloon, MD, MMM, PhD, Unidad Nacional De Oncologia Pediatrica; Study Director: Elena J Ladas, RD, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Leukemia; Childhood Cancer; Malnutrition; Guatemala; Guatemala City
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: AAAR4744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The database is secured in Guatemala research site at UNOP. De-identified data is shared with Columbia University Medical Center via REDCap database system - managed by Columbia University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No