NeuroblastomaNCT03517280
Nutritional Status in Neuroblastoma in Sao Paolo, Brazil
An observational study of Neuroblastoma, run by Columbia University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2018to 10 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who have received previous chemotherapy
- First assessment performed more than 48 hours after the beginning of treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Tratamento do Câncer Infantil
São Paulo, São Paulo, 01409-001
About this study
Official title: 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.
Read the 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
- Keywords
- Malnutrition, Childhood Cancer, Nutrition Aspect of Cancer, Child Malnutrition, Brazil, Sao Paolo
- Medical subject headings
- Neuroblastoma, Malnutrition, Neoplasms, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Z Score
Effect of neuroblastoma treatment in nutritional status: Nutritional status will be measured by BMI Z score
Measured: 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)
Measured: 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
Measured: Up to 1 year post treatment
Secondary outcomes (7)
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)
Measured: 2 years
Incidence of newly diagnosed infection
Study the association of nutritional status and infection classified from moderate to severe neutropenia (ANC < 500)
Measured: 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).
Measured: Up to 1 year post treatment
Disease relapse rate
Investigate the association of nutritional status and disease relapse
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start15 Jul 2018
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Tratamento do Câncer Infantil
- Responsible party
- Sponsor
- Investigators
- Elena Ladas, Phd, RD, Study director, Columbia UniversityKarina Viani, RD, Principal investigator, Instituto de Tratamento do Câncer Infantil, Sao PaoloVicente Odone, MD, PhD, Study chair, Instituto de Tratamento do Câncer Infantil, Sao Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517280
- Sponsor's protocol ID
- AAAR7865
- Status last verified
- May 2024
- First submitted
- 14 Mar 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nutritional Status in the Treatment of Neuroblastoma
- ClinicalTrials.gov ID
- NCT03517280
- Acronym / sponsor ID
- AAAR7865
- Conditions
- Neuroblastoma
- Keywords
- Malnutrition, Childhood Cancer, Nutrition Aspect of Cancer, Child Malnutrition, Brazil, Sao Paolo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Instituto de Tratamento do Câncer Infantil
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Neuroblastoma | – | –Children undergoing treatment for Neuroblastoma at ITACI in Sao Paolo in Brazil who are under the age of 18 years. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have received previous chemotherapy
- First assessment performed more than 48 hours after the beginning of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
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
7 secondary outcomes
Cumulative number of Grade 3/4 toxicities
Time frame: 2 years
Incidence of newly diagnosed infection
Time frame: 2 years
Survival rate
Time frame: Up to 1 year post treatment
Disease relapse rate
Time frame: Up to 1 year post treatment
Cost of care
Time frame: Up to 1 year post treatment
Score on HuPS or HUI
Time frame: Up to 1 year post treatment
Score on 24-hour Dietary Recalls
Time frame: Up to 1 year post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided. 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
Related trials for Neuroblastoma
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Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
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RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
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RecruitingObservational study
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PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Ladas, Phd, RD study director
Columbia University
Karina Viani, RD principal investigator
Instituto de Tratamento do Câncer Infantil, Sao Paolo
Vicente Odone, MD, PhD study chair
Instituto de Tratamento do Câncer Infantil, Sao Paolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by Columbia University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index Z Score (time frame: Up to 1 year post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.