Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

The Role of Nutritional Status in the Treatment of Neuroblastoma

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.

Study Overview

• Status: Completed
• Conditions: Neuroblastoma

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01409-001
      • Instituto de Tratamento do Câncer Infantil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Demographic variables will be collected from medical records, including date of birth, sex, city/state/country of residence, date of diagnosis and ethnicity. Socioeconomic data (per capita annual income and living conditions) will be drawn from the institutions' social work service charts. The data will be collected in hospital - Instituto de Tratamento do Câncer Infantil, in Sao Paolo, Brazil.

The investigators will also collect clinical outcome data from the medical chart. The incidence of infectious toxicity, all Grade 3 and 4 toxicities (defined by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)), death, disease relapse or progression, number of days in the hospital and delays in treatment will be documented during each cycle.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with Neuroblastoma; 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?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Instituto de Tratamento do Câncer Infantil
• Investigators: Study Director: Elena Ladas, Phd, RD, Columbia University; Principal Investigator: Karina Viani, RD, Instituto de Tratamento do Câncer Infantil, Sao Paolo; Study Chair: Vicente Odone, MD, PhD, Instituto de Tratamento do Câncer Infantil, Sao Paolo

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Childhood Cancer; Malnutrition; Brazil; Child Malnutrition; Nutrition Aspect of Cancer; Sao Paolo
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma
• Other Study ID Numbers: AAAR7865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The database is secured in Brazil research site at ITACI. De-identified data is shared with Columbia University Medical Center via REDCap database system - managed by Columbia University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No