Body Composition and Nutritional Status in Pediatric Patients With Hematological Malignancies (HM)

February 22, 2024 updated by: Verónica López Teros, PhD, Universidad de Sonora

Evaluation of Body Composition and Nutritional Status in Pediatric Patients With Hematological Malignancies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

JUSTIFICATION Nutritional assessment of cancer patients is usually performed using conventional anthropometric techniques, which are not sensitive to short-term changes and do not reflect changes in the FFM, FM, and hydration status. Assessing body composition using reference techniques such as deuterium oxide dilution (DOD), and also using field methods (BIA and anthropometry), which are more accessible in clinical practice, can detect short-term changes in children and adolescents with HM.

In cancer patients, protein and muscle stores are frequently affected; an increase in FM and a decrease in FFM were observed within the first 6 months of antineoplastic treatment. The DOD technique identifies three compartments (total body water, FFM, and FM). Similar changes in body composition are seen in patients with breast cancer; the work carried out by Limón-Miró et al; where it was observed that an individualized nutritional intervention preserved FFM while reducing FM, both associated with quality of life and survival in breast cancer patients. This highlights the importance of specialized nutritional and body composition evaluations in the comprehensive treatment of cancer patients; in children and adolescents with HM, monitoring body composition combined with a nutrition intervention, could reduce the deterioration of FFM and provide a window to assess prognosis, clinical outcome, and survival of HM pediatric patients.

HYPOTHESES The body composition (fat and fat-free mass) and nutritional status of pediatric patients with HM in active treatment will be different at the beginning vs. the end of the study (6 months), in addition to showing differences against the healthy reference population.

GENERAL OBJECTIVE To evaluate changes in body composition and nutritional status in pediatric patients with HM under active treatment.

SPECIFIC OBJECTIVES

  • To evaluate nutritional status using anthropometric and dietary indicators at the beginning and 6 months after the intervention.
  • To assess fat mass and fat-free mass using reference and field techniques, at baseline and 6 months after the intervention.
  • To establish a protocol on monitoring nutrition status and body composition that can be applied routinely in clinical practice.

METHODOLOGY Study design This is a pre-test/post-test design. Children from 2 to 14 years old with a diagnosis of HM two areas of Mexico (Hermosillo, Sonora / Guadalajara, Jalisco) will participate.

Sample size: To determine the sample size, we will work on the assumptions of a standard deviation (SD) of Fat-Free Mass (FFM) of 2.19 Kg, with a Variance of 4.8 Kg, a Zα of 1.96 for a p = 0.05, with a mean difference (Ԁ) of 1 Kg. The sample size was calculated considering the Beta error of 20% (B = 0.84), depending on the availability of the number of patients who agreed to participate, as well as those excluded by established criteria. Based on the data mentioned, the estimated sample size calculation is 38 participants, as detailed in the following equation.

N = ((Zα + Zβ) ^ 2 〖(DE)〗 ^ 2) / 〖(d)〗 ^ 2 = 38 participants Clinical record: The principles of the Official Mexican Norm (NOM) NOM-024-SSA3-201 will be followed, which establishes the functional objectives and functionalities that must be followed in the use of electronic clinical records. For this purpose, a confidential file number will be assigned, so that when analyzing the biological samples or data collected in the field, no access will be given to the names, address, telephone number, or related information that may be exposed to the participant.

Screening: Predictive screening will be used for the "Nutrition Screening Tool For Childhood Cancer (SCAN)" which consists of 6 questions. This tool identifies the need for a nutritional intervention according to the symptoms of the patients who classify at risk of malnutrition. Screening should be applied to all study subjects at each consultation or weekly to patients who are hospitalized since they are at high risk of malnutrition at the time of diagnosis and increases in the stages of treatment. The Lansky pediatric scale will also be applied, which allows evaluating the general condition of the patient, representing the degree of autonomy in the activities of daily life. In addition, the PedsQL Cancer Module © will be used, which is derived from the Pediatric Quality of Life Questionnaire (PedsQL), which is a generic instrument designed for children and parents to assess the quality of life as a self-report.

Dietary evaluation: The ENSANUT frequency questionnaire will be applied for the respective age groups: preschoolers, schoolchildren, and adolescents.

Anthropometry Weight and height: Body weight will be measured (electronic scale with 0.150 + 0.05 kg scales) or child scale (0-20 kg). Height will be measured by SECA stadiometers or infantometers, as required to the nearest 0.1 cm.

Mid-upper arm circumference (MUAC): This measure allows the identification of malnutrition in children under 5 years of age without taking weight, height, and age, by measuring the arm circumference at its midpoint.

Tricipital skinfold (TSF): With the participant standing, with the feet together, the shoulders relaxed and the arms hanging relaxed at the sides. The examiner will stand on the right side of the patient and place the top point on the back surface of the arm in the same area as the midpoint marked for the arm circumference. The skin fold of the skin and subcutaneous adipose tissue will be gently grasped with the thumb and index finger, approximately 1.0 cm above the point where the skin was scored, with the skin fold parallel to the longitudinal axis of the upper arm. The jaws of the calipers will be placed at the level that the skin was marked, these should be positioned perpendicular to the length of the fold. The skinfold will be held gently and the skinfold thickness will be measured to the nearest 1mm.

Waist circumference (WC): The waist circumference will be measured with a retractable tape at the level of the umbilical scar in a standing position and after exhaling.

All measurements will be processed by the Anthro software of the World Health Organization, for the calculation of nutritional indices such as Z score of weight/age, height/age, and weight/height in children <60 months, BMI-age- sex, and height/age in children> 60 months. A physical examination will be performed to observe signs of malnutrition (loss of subcutaneous fat, muscle wasting, edema, etc.).

Body composition Deuterium oxide dilution: Total body water will be measured by dilution of deuterium oxide (DOD) using Fourier transform infrared spectroscopy (FTIR) with a saliva sample. The doses of deuterium will be those recommended for field studies by the International Atomic Energy Agency (an amount that does not represent a risk for minors).

The measurement will be taken once the patient has gone to the bathroom, sterile material will be used taking care of the cleanliness and safety of the personnel in charge of the measurement. A pre-dose saliva sample will be taken, once the dose is calculated by the patient's weight, the DOD will be administered, this should be taken with syringe to avoid spilling the dose. After 3 hours, a post-dose saliva sample will be taken, at the time of calculation, it will be taken into account if the patient ingested extra fluids.

Electrical bioimpedance (BIA): BIA is considered a simple, fast, and non-invasive technique that allows the estimation of total body water (TBW), fat-free mass (FFM), and, by difference, fat mass (FM). The patient must be in the supine position at the time of measurement for at least 5 minutes before starting. 4 electrodes will be placed on its left ends, two on the hand and two on the foot, 5 cm away from each other, a current of 50 mHz is administered, then a resistance and reactance reading is taken to obtain the result of the test. impedance, following the standardized methodology.

For the study population, it is proposed to use the equation validated in the child population proposed by Ramírez E., et al. In this way, when knowing the FFM, the FM will be estimated by difference with the total body weight.

FFM(kg) = 0.661 x Ht2 / R + 0.200 x Wt - 0.320 Where Ht is height in cm squared, R is resistance, and Wt is weight in kg. Individualized nutritional intervention

Statistic analysis Descriptive statistics will be used using NCSS v11. To evaluate the effectiveness of the intervention, the t-student test or non-parametric tests will be performed depending on the distribution of the data. For BIA an algorithm will be used to predict total body water for the calculation of FFM and FM compared to the results of dilution with deuterium. Intention-to-treat analysis will also be performed, which should be seen more as a global strategy for the design, execution, and analysis of clinical trials, rather than solely as an alternative analysis.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • Recruiting
        • Universidad de Sonora
        • Contact:
          • Veronica Lopez-Teros, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients diagnosed with HM
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FFM 1
Time Frame: at enrrollment
Fat free mass in kilograms (Kg)
at enrrollment
FFM 2
Time Frame: 6 months
Fat free mass in kilograms (Kg)
6 months
FM 1
Time Frame: at enrrollment
Fat mass in kilograms (Kg)
at enrrollment
FM 2
Time Frame: 6 months
Fat mass in kilograms (Kg)
6 months
TBW 1
Time Frame: at enrrollment
Total body water in kilograms (Kg)
at enrrollment
TBW 2
Time Frame: 6 months
Total body water in kilograms (Kg)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: through study duration, an average of 6 months, once a month
Body mass index for age in Kg/m^2
through study duration, an average of 6 months, once a month
Weight
Time Frame: through study duration, an average of 6 months, once a month
Weight in kilograms (Kg)
through study duration, an average of 6 months, once a month
MUAC
Time Frame: through study duration, an average of 6 months, once a month
Mid arm muscle circumference in centimeters (cm)
through study duration, an average of 6 months, once a month
Tricep skin fold (TSK)
Time Frame: through study duration, an average of 6 months, once a month
Tricep skinfold in milimeters (mm)
through study duration, an average of 6 months, once a month
WC
Time Frame: through study duration, an average of 6 months, once a month
Waist circumference in centimeters (cm)
through study duration, an average of 6 months, once a month
R
Time Frame: through study duration, an average of 6 months, once a month
Resistance in Ohms
through study duration, an average of 6 months, once a month
Xc
Time Frame: through study duration, an average of 6 months, once a month
Reactance in Ohms
through study duration, an average of 6 months, once a month
Height
Time Frame: through study duration, an average of 6 months, once a month
Height in cm
through study duration, an average of 6 months, once a month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Sonora

Collaborators

Hospital Civil de Guadalajara
International Atomic Energy Agency
Centro de Investigación en Alimentación y Desarrollo A.C.

Investigators

  • Study Director: Veronica López Teros, PhD, Universidad de Sonora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USonora

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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