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临床试验/NCT03517280
NCT03517280已完成不适用

The Role of Nutritional Status in the Treatment of Neuroblastoma

Columbia University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Measurement from Bioelectrical Impedance Analysis (BIA)

研究概览

简要总结

This study proposes to investigate the effect of treatment of neuroblastoma on nutritional status, assessed by body mass index (BMI) z score, and body composition evaluated by mid-upper arm circumference (MUAC), from diagnosis through 1-year post end of treatment. The study also aims to investigate the nutritional status and its role in toxicities, infection, survival rates, disease relapse, cost of care and readmission rates, as well as health-related quality of life. The study will take place in Sao Paolo in Brazil, where an estimated sample of 50 children with neuroblastoma will be recruited for the period of 2 years.

详细描述

In Brazil, cancer represents the leading cause of death by disease in children and adolescents from 1 to 19 years old. Neuroblastomas correspond to nearly 10% of all cancer diagnoses among children younger than 15 years of age, with an incidence of 1 case per 100,000 children of this age group. About 500 new cases of neuroblastoma (NB) are diagnosed annually in Brazil. The complexity and intensity of treatment result in several treatment-related toxicities (TRT) that make it challenging to maintain nutritional status in these nutritionally at-risk patients. In Brazil, up to 26% of undernutrition at diagnosis has been found in patients with solid tumors. In neuroblastoma, high prevalence rates of malnutrition have been reported elsewhere with up to 80% of children at diagnosis and 20-50% during treatment classified as undernourished. It's important to underscore that nutritional status is a modifiable risk factor, therefore it needs more attention and close monitoring. It is important to better comprehend the effect of treatment for neuroblastoma on nutritional status and body composition, for which prospective longitudinal studies are required. Therefore, in this prospective cohort study, the investigators will evaluate the fluctuations in nutritional status over the course of treatment in children with neuroblastoma at the study center in São Paulo, Brazil. The results of this study will drive the development of evidence-based guidelines for the nutritional care of children with neuroblastoma and set research priorities for subsequent investigations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of high-risk neuroblastoma at ITACI, according to the Pediatric Oncology Group (POG)/Children's Cancer Study Group (CCG) classification (International Neuroblastoma Staging System (INSS) stage)
  • Age under 18 years
  • Informed consent from a legal guardian to participate in the study

排除标准

  • Patients who have received previous chemotherapy
  • First assessment performed more than 48 hours after the beginning of treatment

结局指标

主要结局

Measurement from Bioelectrical Impedance Analysis (BIA)

时间窗: Up to 1 year post treatment

Effect of neuroblastoma treatment in body composition: Body composition will be measured by BIA

Mid-upper arm circumference (MUAC)

时间窗: Up to 1 year post treatment

Effect of neuroblastoma treatment in body composition: Body composition will be measured by mid-upper arm circumference (MUAC)

Body Mass Index Z Score

时间窗: Up to 1 year post treatment

Effect of neuroblastoma treatment in nutritional status: Nutritional status will be measured by BMI Z score

次要结局

  • Cumulative number of Grade 3/4 toxicities(2 years)
  • Survival rate(Up to 1 year post treatment)
  • Cost of care(Up to 1 year post treatment)
  • Disease relapse rate(Up to 1 year post treatment)
  • Incidence of newly diagnosed infection(2 years)
  • Score on HuPS or HUI(Up to 1 year post treatment)
  • Score on 24-hour Dietary Recalls(Up to 1 year post treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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