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Nutritional Status in Children With ALL in Guatemala

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ClinicalTrials.gov Identifier: NCT03471416
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Unidad nacional de Oncologia Pediatrica, Guatemala
Information provided by (Responsible Party):
Elena Ladas, Columbia University

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Status in Children With Acute Lymphoblastic Leukemia Undergoing Treatment at the National Pediatric Oncology Unit in Guatemala City, Guatemala
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022


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



Primary Outcome Measures :
  1. Association of BMI and Body Composition [ Time Frame: Up to 6 months after treatment ]
    Body composition will be measured by DEXA.

  2. Association of TSFT and Body Composition [ Time Frame: Up to 6 months after treatment ]
    Body composition will be measured by DEXA.

  3. Association of MUAC and Body Composition [ Time Frame: Up to 6 months after treatment ]
    Body composition will be measured by DEXA.


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: Up to 6 months after treatment ]
    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.

  2. Habitual Activity Estimation Scale [ Time Frame: Up to 6 months after treatment ]
    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.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471416


Contacts
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Contact: Elena J Ladas, RD, PhD 212.305.7835 ejd14@cumc.columbia.edu
Contact: Suvekshya Aryal, MPH 646-317-2070 sa3234@cumc.columbia.edu

Locations
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Guatemala
Unidad Nacional de Oncología Pediátrica Recruiting
Guatemala City, Guatemala
Contact: Federico Antiloon, MD, MMM, PhD       fantillo@ufm.edu   
Principal Investigator: Federico Antiloon, MD, MMM, PhD         
Sub-Investigator: Ana Lucia Molina, RD         
Sponsors and Collaborators
Columbia University
Unidad nacional de Oncologia Pediatrica, Guatemala
Investigators
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Study Chair: Ronald Barr, MB, ChB, MD McMaster University
Principal Investigator: Federico Antiloon, MD, MMM, PhD Unidad Nacional de Oncología Pediátrica
Study Director: Elena J Ladas, RD, PhD Columbia University

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Responsible Party: Elena Ladas, Sid and Helaine Lerner Assistant Professor for Global Integrative Medicine in the Division of Hematology/Oncology/Stem Cell Transplant in the Department of Pediatrics (in Epidemiology and in the Institute of Human Nutrition), Columbia University
ClinicalTrials.gov Identifier: NCT03471416     History of Changes
Other Study ID Numbers: AAAR4744
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Ladas, Columbia University:
Guatemala
Guatemala City
Malnutrition
Leukemia
Childhood Cancer
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases