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NCT Number: NCT03517280

Nutritional Status in Neuroblastoma in Sao Paolo, Brazil

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.

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Key information

Conditions

Neuroblastoma Child Nutrition Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Nutrition Disorders Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Tratamento do Câncer Infantil

São Paulo, 01409-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. Cumulative number of Grade 3/4 toxicities

    Time frame: 2 years

    Investigate association of nutritional status and the occurrence of grade 3/4 toxicities using NCI Common Toxicity Criteria (CTC)

  2. Incidence of newly diagnosed infection

    Time frame: 2 years

    Study the association of nutritional status and infection classified from moderate to severe neutropenia (ANC < 500)

  3. Survival rate

    Time frame: 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).

  4. Disease relapse rate

    Time frame: Up to 1 year post treatment

    Investigate the association of nutritional status and disease relapse

  5. Cost of care

    Time frame: 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.

  6. Score on HuPS or HUI

    Time frame: 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.

  7. Score on 24-hour Dietary Recalls

    Time frame: Up to 1 year post treatment

    Investigate the association of nutritional status and diet quality, measured by 24h dietary recalls

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Instituto de Tratamento do Câncer Infantil

Registry information

Official study title

The Role of Nutritional Status in the Treatment of Neuroblastoma

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 7, 2018
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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