Nutritional Status in Children With ALL in Guatemala

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03471416
• Other study ID #: AAAR4744
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: July 2019
• Source: Columbia University
• Contact: Elena J Ladas, RD, PhD
• Phone: 212.305.7835
• Email: ejd14[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Guatemala	Unidad Nacional de Oncología Pediátrica	Guatemala City

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Unidad nacional de Oncologia Pediatrica, Guatemala

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of BMI and Body Composition	Body composition will be measured by DEXA.	Up to 6 months after treatment
Primary	Association of TSFT and Body Composition	Body composition will be measured by DEXA.	Up to 6 months after treatment
Primary	Association of MUAC and Body Composition	Body composition will be measured by DEXA.	Up to 6 months after treatment
Secondary	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
Secondary	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