Body Composition and Nutritional Status in Pediatric Patients With Hematological Malignancies

NCT04764695 | Completed

• 1 other identifier: USonora
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Annually 400,000 children are diagnosed with cancer in the world. Approximately 90% live in low/middle-income countries, with survival rates of 10-30%. In Mexico, children and adolescents' hospital admissions for cancer are mainly leukemias (46%), being acute lymphoblastic leukemia (ALL) the most common. Half of ALL patients have an altered nutritional status at the time of diagnosis. Nutritional assessment is performed using conventional anthropometric measures, which are not sensitive to changes in fat-free mass and fat mass (FFM and FFM). Our objective is to evaluate the body composition and nutritional status in pediatric patients with HM. This is a pre-test/post-test clinical trial. Children 2-14 y olds diagnosed with leukemia, myeloma and lymphoma in any stage of oncological treatment will participate. The nutritional status will be evaluated using questionnaires and body composition. Measurements will occur at the enrrollment of the study and 6 months after.

Conditions

Childhood Cancer; Child Malnutrition; Childhood Obesity

Keywords

Children; Body Composition; Nutrition

Outcome Measures

Primary Outcomes (6)

• FFM 1

  Fat free mass in kilograms (Kg)

  at enrrollment

• FFM 2

  Fat free mass in kilograms (Kg)

  6 months

• FM 1

  Fat mass in kilograms (Kg)

  at enrrollment

• FM 2

  Fat mass in kilograms (Kg)

  6 months

• TBW 1

  Total body water in kilograms (Kg)

  at enrrollment

• TBW 2

  Total body water in kilograms (Kg)

  6 months

Secondary Outcomes (8)

• BMI

  through study duration, an average of 6 months, once a month

• Weight

  through study duration, an average of 6 months, once a month

• MUAC

  through study duration, an average of 6 months, once a month

• Tricep skin fold (TSK)

  through study duration, an average of 6 months, once a month

• WC

  through study duration, an average of 6 months, once a month

Study Arms (1)

Patients diagnosed with HM

EXPERIMENTAL

As it is a pre-test / post-test design, the child himself will be the control at the end of the study. Additionally, children without ALL of the same age and sex will be taken as reference. The potential of including paired measurements against healthy children for external control is analyzed.

Diagnostic Test: D2O dilution technique

Interventions

D2O dilution technique DIAGNOSTIC_TEST

Body composition will be measured with the deuterium dilution technique and electrical bioimpedance, as well as anthropometric indicators at the beginning and 6 months later.

Patients diagnosed with HM

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients in remission stage (4 - 6 weeks)
• Life expectancy\> 6 months and sufficient general conditions according to scales (Lansky ≥ 50 points for children \<16 years)
• Histopathological/molecular clinical confirmation of the HM diagnosis
• Signature of the consent by the relative or legal guardian of the patient and as well as the consent informed by the patient.

You may not qualify if:

• Pathological conditions that can alter body composition (diabetes, hypothyroidism, among others)
• Patients with sepsis that causes hemodynamic compromise and cannot be evaluated
• Severely ill patients unable to participate in baseline measurements
• Relapsed patients
• Patients with developmental problems of a genetic order as well as innate errors of metabolism

Sponsors & Collaborators

• Universidad de Sonora: lead
• International Atomic Energy Agency: collaborator
• Hospital Civil de Guadalajara: collaborator
• Centro de Investigación en Alimentación y Desarrollo A.C.: collaborator

Study Sites (1)

Universidad de Sonora

Hermosillo, Sonora, 83000, Mexico

Location

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MeSH Terms

Conditions

Neoplasms; Child Nutrition Disorders; Pediatric Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica López Teros, PhD

  Universidad de Sonora

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking during data analysis. Technicians and investigators will not be aware of the participants personal data and particularities.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Clinical trial with a pre-test/post-test design. Intervention group: Children and adolescents between 2 and 14 years old with a diagnosis of HM in any treatment stage who agree to participate in the project with the approval of their legal guardian. Control group: Being a pre-test/post-test design, the same child will be the control at the end of the intervention. Additionally, children without ALL of the same age and sex will be taken as reference. The potential of including paired measurements against healthy children for external control is analyzed.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 21, 2021
• Study Start: January 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)