Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

Completed

• Conditions: Neuroblastoma

• Registration Number: NCT03517280
• Lead Sponsor: Columbia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-07
• Study Start: 2018-07-15
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement from Bioelectrical Impedance Analysis (BIA)	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)	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	Up to 1 year post treatment	Effect of neuroblastoma treatment in nutritional status: Nutritional status will be measured by BMI Z score

Secondary Outcome Measures

Name	Time	Method
Cumulative number of Grade 3/4 toxicities	2 years	Investigate association of nutritional status and the occurrence of grade 3/4 toxicities using NCI Common Toxicity Criteria (CTC)
Survival rate	Up to 1 year post treatment	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).
Cost of care	Up to 1 year post treatment	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.
Disease relapse rate	Up to 1 year post treatment	Investigate the association of nutritional status and disease relapse
Incidence of newly diagnosed infection	2 years	Study the association of nutritional status and infection classified from moderate to severe neutropenia (ANC \< 500)
Score on HuPS or HUI	Up to 1 year post treatment	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.
Score on 24-hour Dietary Recalls	Up to 1 year post treatment	Investigate the association of nutritional status and diet quality, measured by 24h dietary recalls

Trial Locations

Locations (1)

Instituto de Tratamento do Câncer Infantil; 🇧🇷 São Paulo, Sao Paulo, Brazil