Nutritional Status in Children With ALL in Guatemala

NCT ID: NCT03471416

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-09-01

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with ALL

Children undergoing ALL treatment at UNOP Guatemala who are under the age of 18 years.

No interventions assigned to this group

Healthy siblings

Healthy siblings of children undergoing ALL treatment at UNOP Guatemala who are under the age of 18 years.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unidad nacional de Oncologia Pediatrica, Guatemala

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Barr, MB, ChB, MD

Role: STUDY_CHAIR

McMaster University

Federico Antiloon, MD, MMM, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad Nacional de Oncología Pediátrica

Elena J Ladas, RD, PhD

Role: STUDY_DIRECTOR

Columbia University

Locations

Unidad Nacional de Oncología Pediátrica (UNOP)

Guatemala City, , Guatemala

Countries

Guatemala

Other Identifiers

AAAR4744

Identifier Type: -

Identifier Source: org_study_id