Nutritional Intervention in Acute Lymphoblastic Leukemia

Summary

Participation Requirements

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 deu...

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 Z? of 1.96 for a p = 0.05, with a mean difference (?) 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 = ((Z? + Z?) ^ 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).

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