Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Role of Nutritional Status in the Treatment of Neuroblastoma

Conditions
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Neuroblastoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients who have received previous chemotherapy First assessment performed more than 48 hours after the beginning of treatment

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with Neuroblastoma<br>Children undergoing treatment for Neuroblastoma at ITACI in Sao Paolo in Brazil who are under the age of 18 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index Z Score | Effect of neuroblastoma treatment in nutritional status: Nutritional status will be measured by BMI Z score | Up to 1 year post treatment | 
| Mid-upper arm circumference (MUAC) | Effect of neuroblastoma treatment in body composition: Body composition will be measured by mid-upper arm circumference (MUAC) | Up to 1 year post treatment | 
| Measurement from Bioelectrical Impedance Analysis (BIA) | Effect of neuroblastoma treatment in body composition: Body composition will be measured by BIA | Up to 1 year post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of Grade 3/4 toxicities | Investigate association of nutritional status and the occurrence of grade 3/4 toxicities using NCI Common Toxicity Criteria (CTC) | 2 years | 
| Incidence of newly diagnosed infection | Study the association of nutritional status and infection classified from moderate to severe neutropenia (ANC < 500) | 2 years | 
| Survival rate | Survival is defined by both overall survival (time from enrollment to death from any cause) and event-free survival (time from enrollment to the first episode of relapse, disease progression or death). | Up to 1 year post treatment | 
| Disease relapse rate | Investigate the association of nutritional status and disease relapse | Up to 1 year post treatment | 
| Cost of care | Investigate the association of nutritional status and the cost of care defined by the sum of the cost of duration of hospital stay and cost of readmission rates. We will evaluate the values individually and collectively. | Up to 1 year post treatment | 
| Score on HuPS or HUI | Health-related quality of life will be measured by the Health Utilities Preschool(HuPS) survey for 2 -5 years old or by Health Utilities Index (HUI) for 5 years and older (assessment is not considered for children under 2 years), during and after treatment, and its association with nutritional status and body composition. These are complementary instruments for use in the contiguous age groups. They are scored in the same way. | Up to 1 year post treatment | 
| Score on 24-hour Dietary Recalls | Investigate the association of nutritional status and diet quality, measured by 24h dietary recalls | Up to 1 year post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Childhood Cancer, Nutrition Aspect of Cancer, Child Malnutrition, Brazil, Sao Paolo