Evaluation of Body Composition and Nutritional Status in Pediatric Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- FFM 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Masking during data analysis. Technicians and investigators will not be aware of the participants personal data and particularities.
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: D2O dilution technique (Diagnostic Test)
结局指标
主要结局
FFM 1
时间窗: at enrrollment
Fat free mass in kilograms (Kg)
TBW 2
时间窗: 6 months
Total body water in kilograms (Kg)
FM 1
时间窗: at enrrollment
Fat mass in kilograms (Kg)
FM 2
时间窗: 6 months
Fat mass in kilograms (Kg)
FFM 2
时间窗: 6 months
Fat free mass in kilograms (Kg)
TBW 1
时间窗: at enrrollment
Total body water in kilograms (Kg)
次要结局
- Xc(through study duration, an average of 6 months, once a month)
- BMI(through study duration, an average of 6 months, once a month)
- Weight(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)
- MUAC(through study duration, an average of 6 months, once a month)
- WC(through study duration, an average of 6 months, once a month)
- R(through study duration, an average of 6 months, once a month)
- Height(through study duration, an average of 6 months, once a month)
研究者
Verónica López Teros, PhD
Principal Investigator, Clinical Professor
Universidad de Sonora