Clinical trial NCT03471416: Nutritional Status in Children With ALL in Guatemala
Official title: Nutritional Status in Children With Acute Lymphoblastic Leukemia (ALL) Undergoing Treatment at the National Pediatric Oncology Unit in Guatemala City, Guatemala
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: Guatemala
Guatemala City
Malnutrition
Leukemia
Childhood Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Unidad nacional de Oncologia Pediatrica, Guatemala
First posted: 2018-03-20
Enrollment: 109
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Association of BMI and Body Composition
timeFrame: Up to 6 months after treatment
measure: Association of TSFT and Body Composition
timeFrame: Up to 6 months after treatment
measure: Association of MUAC and Body Composition
timeFrame: Up to 6 months after treatment
Secondary outcomes:
measure: Body Composition
timeFrame: Up to 6 months after treatment
measure: Habitual Activity Estimation Scale
timeFrame: Up to 6 months after treatment
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Unidad Nacional de Oncología Pediátrica (UNOP)
Study officials:
affiliation: McMaster University
name: Ronald Barr, MB, ChB, MD
role: STUDY_CHAIR
affiliation: Unidad Nacional de Oncología Pediátrica
name: Federico Antiloon, MD, MMM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Elena J Ladas, RD, PhD
role: STUDY_DIRECTOR
References: