Nutritional Intervention in Acute Lymphoblastic Leukemia (ALL)

• ClinicalTrials.gov Identifier: NCT04764695
• Recruitment Status: Not yet recruiting
• First Posted: February 21, 2021
• Last Update Posted: February 21, 2021
• Sponsor: Universidad de Sonora
• Collaborators: International Atomic Energy Agency; Hospital Civil de Guadalajara; Centro de Investigación en Alimentación y Desarrollo A.C.
• Information provided by (Responsible Party): Verónica López Teros, PhD, Universidad de Sonora

Study Description

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 effect of an individualized food-based nutritional intervention according to the nutritional status, body composition and comorbidities in pediatric patients with ALL. This is a pre-test/post-test clinical trial. Children 2-14 y olds diagnosed with ALL and in the remission stage (4-6 weeks post-diagnosis) will participate. The nutritional status will be evaluated using questionnaires and body composition. The intervention will be a 6 mo individualized food-based nutrition plan changing meal plans every 2 wk; every plan provides 5 interchangeable meals, adapting to personal preferences and symptoms related to antineoplastic treatment (nausea, diarrhea, taste alteration, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the nutritional intervention. Effectiveness of the intervention will be assessed using a paired test dependant on the distribution of the data.

Condition or disease	Intervention/treatment	Phase
Acute Lymphoblastic Leukemia; Childhood Cancer; Child Malnutrition; Childhood Obesity	Dietary Supplement: Individualized Nutritional Treatment	Not Applicable

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 a reference technique 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 ALL.

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 a specialized nutritional intervention in the comprehensive treatment of cancer patients; in children and adolescents with ALL, 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 ALL pediatric patients in remission.

HYPOTHESES

An individualized food-based nutritional intervention for 6 months in pediatric patients with ALL in remission:

• Promotes maintenance and improvement of the FFM
• Promotes the normalization of FM
• Will show differences in body composition in children with ALL, before and after nutritional intervention

GENERAL OBJECTIVE To assess the impact of an individualized food-based nutritional intervention (6 months) on the body composition of children diagnosed with ALL.

SPECIFIC OBJECTIVES

• To assess the nutritional status of children diagnosed with ALL based on anthropometric and dietary indicators before and after 6 months of individualized nutritional intervention.
• To evaluate fat mass and fat-free mass using reference and field techniques, before and after 6 months of individualized nutritional intervention in minors diagnosed with ALL.
• To analyze the change in body composition after 6 months of individualized nutritional intervention in minors diagnosed with ALL.
• To establish a protocol on nutritional monitoring of patients with acute lymphoblastic leukemia that can be applied in clinical practice.
• To monitor body composition in the medium term (3 years) and associate it with quality of life variables.

METHODOLOGY Study design This is a clinical trial with a pre-test/post-test design. Children from 2 to 14 years old with a diagnosis of Acute Lymphoblastic Leukemia (ALL) in remission stage (4 - 6 weeks) from 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 isotope ratio mass spectrometry with a urine sample. Our laboratory has reduced the dose necessary to obtain the enrichment of> 800 ppm in children and adults, which is 0.2 g of deuterium/kg of body weight, 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 urine sample will be taken, once the dose is calculated by the patient's weight, the DOD plus 50 ml of natural water will be administered, this should be taken with a straw to avoid spilling the dose. After 4 hours, a post-dose urine sample will be taken, at the time of calculation, it will be taken into account if the patient ingested extra fluids.

Urine samples will be analyzed using isotope ratio mass spectrometry to obtain the values of deuterium spaces, total body water and calculate the FFM and FM.

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 After the diagnosis of ALL is established, an individualized food-based nutritional plan will be given to study patients. The dietary intervention will be developed based on the nutritional status of the patients, habits, schedule, activities, cultural preferences since all these characteristics are critical factors that determine adherence to the nutritional plan. Currently, there are no standardized protocols for the nutritional management of patients with acute lymphoblastic leukemia in Mexico.

Some articles propose levels that are necessary to achieve or maintain, such as weight/age Z-score between -2 and 2, <30% fat/day (mainly monounsaturated and polyunsaturated fatty acids), 55 - 60% carbohydrates ( whole grains), we propose to use 1 - 1.5 g of protein/kg/day depending on the age of the patient. If excess weight / fat mass is detected, a mild calorie restriction will be evaluated. Every two weeks a new 7-day meal plan will be provided with 5 interchangeable meals per day. At each visit, they will be asked about food intake, percentage of adherence to the nutritional plan, modifications, symptoms related to treatment (nausea, diarrhea, alteration in taste, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the 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. It is the recommended strategy, especially in pragmatic trials. The intention-to-treat analysis gives an estimate of the benefit of a treatment closer to daily practice (effectiveness).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment

Intervention Model Description

Clinical trial with a pre-test/post-test design. Intervention group: Children and adolescents between 2 and 14 years old with a diagnosis of ALL in the remission 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.

• Masking: None (Open Label)
• Masking Description: Masking during data analysis. Technicians and investigators will not be aware of the participants personal data and particularities.
• Primary Purpose: Treatment
• Official Title: Effect of a Food-based Nutrition Intervention on Body Composition of Children and Adolescents Diagnosed With Acute Lymphoblastic Leukemia (2-14 y)
• Estimated Study Start Date: January 30, 2022
• Estimated Primary Completion Date: August 30, 2024
• Estimated Study Completion Date: December 30, 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: Patients diagnosed with ALL with individualized nutritional treatment; As it is a pre-test / post-test design, the child himself 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.

Dietary Supplement: Individualized Nutritional Treatment; Pre-test / post-test clinical trial. Children aged 2-14 years in the remission stage of ALL (4-6 weeks post-diagnosis) will participate. The nutritional status will be evaluated using a diagnostic questionnaire (SCAN), habitual diet (ENSANUT consumption frequency questionnaire) and body composition (dilution with deuterium oxide, electrical bioimpedance and anthropometry). Subsequently, an individualized nutritional plan will be implemented for 6 months with the following distribution of nutrients: <30% fat / day, 55-60% carbohydrates and 1-1.5 g protein / kg / day. Every two weeks a new 7-day eating plan will be provided with 5 interchangeable meals, adapting to food intake, percentage of adherence to the nutritional plan, modifications and symptoms related to treatment (nausea, diarrhea, taste alteration, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the intervention.

Outcome Measures

Primary Outcome Measures :

1. FFM pre-intervention [ Time Frame: pre-intervention ]
   Fat free mass in kilograms (Kg)
2. FFM post-intervention [ Time Frame: immediately after the intervention ]
   Fat free mass in kilograms (Kg)
3. FM pre-intervention [ Time Frame: pre-intervention ]
   Fat mass in kilograms (Kg)
4. FM post-intervention [ Time Frame: immediately after the intervention ]
   Fat mass in kilograms (Kg)
5. TBW pre-intervention [ Time Frame: pre-intervention ]
   Total body water in kilograms (Kg)
6. TBW post-intervention [ Time Frame: immediately after the intervention ]
   Total body water in kilograms (Kg)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 ALL 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

Contacts and Locations

Contacts

Contact: Veronica López Teros, PhD; 6621224955; veronica.lopez@unison.mx

Contact: Alan E Guzmán León, MSc; 6621715651; alan.guzman@unison.mx

Locations

Mexico

Universidad de Sonora

Hermosillo, Sonora, Mexico, 83000

Sponsors and Collaborators

Universidad de Sonora

International Atomic Energy Agency

Hospital Civil de Guadalajara

Centro de Investigación en Alimentación y Desarrollo A.C.

Investigators

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

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• Responsible Party: Verónica López Teros, PhD, Principal Investigator, Clinical Professor, Universidad de Sonora
• ClinicalTrials.gov Identifier: NCT04764695
• Other Study ID Numbers: USonora
• First Posted: February 21, 2021
• Last Update Posted: February 21, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Verónica López Teros, PhD, Universidad de Sonora:

Acute Lymphoblastic Leukemia; Children; Body Composition; Nutrition

Additional relevant MeSH terms:

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Malnutrition; Pediatric Obesity; Child Nutrition Disorders; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nutrition Disorders; Obesity; Overnutrition; Overweight; Body Weight