The Role of Nutritional Status in the Treatment of Neuroblastoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuroblastoma
- Sponsor
- Columbia University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Measurement from Bioelectrical Impedance Analysis (BIA)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Measurement from Bioelectrical Impedance Analysis (BIA)
Time Frame: 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)
Time Frame: 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
Time Frame: Up to 1 year post treatment
Effect of neuroblastoma treatment in nutritional status: Nutritional status will be measured by BMI Z score
Secondary Outcomes
- Cumulative number of Grade 3/4 toxicities(2 years)
- Survival rate(Up to 1 year post treatment)
- Cost of care(Up to 1 year post treatment)
- Disease relapse rate(Up to 1 year post treatment)
- Incidence of newly diagnosed infection(2 years)
- Score on HuPS or HUI(Up to 1 year post treatment)
- Score on 24-hour Dietary Recalls(Up to 1 year post treatment)