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Spots Global Cancer Trial Database for Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

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Trial Identification

Brief Title: Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

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

Study ID: NCT03517280

Conditions

Neuroblastoma

Interventions

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Instituto de Tratamento do Câncer Infantil, São Paulo, Sao Paulo, Brazil

Contact Details

Name: Elena Ladas, Phd, RD

Affiliation: Columbia University

Role: STUDY_DIRECTOR

Name: Karina Viani, RD

Affiliation: Instituto de Tratamento do Câncer Infantil, Sao Paolo

Role: PRINCIPAL_INVESTIGATOR

Name: Vicente Odone, MD, PhD

Affiliation: Instituto de Tratamento do Câncer Infantil, Sao Paolo

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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