Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

NCT ID: NCT03517280

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2023-05-10

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.

Conditions

Neuroblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with Neuroblastoma

Children undergoing treatment for Neuroblastoma at ITACI in Sao Paolo in Brazil who are under the age of 18 years.

No interventions assigned to this group

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Tratamento do Câncer Infantil

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Ladas, Phd, RD

Role: STUDY_DIRECTOR

Columbia University

Karina Viani, RD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Tratamento do Câncer Infantil, Sao Paolo

Vicente Odone, MD, PhD

Role: STUDY_CHAIR

Instituto de Tratamento do Câncer Infantil, Sao Paolo

Locations

Instituto de Tratamento do Câncer Infantil

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

AAAR7865

Identifier Type: -

Identifier Source: org_study_id