Clinical trial NCT03976830: Nutrition in Pediatric Oncology in Central America
Official title: The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Central America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition in Cancer Survival and Treatment
Keywords: Malnutrition
Childhood Cancer
Central America
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Hospital Escuela Universitario, Honduras
First posted: 2019-06-06
Enrollment: 126
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with childhood cancer in participating sites in Central American countries specified in the protocol, will be recruited at diagnosis. A total of 1000 patients are anticipated for the study in AHOPCA affiliated institutions and patients will be recruited and consented (including parents) by a designated researcher.

Brief summary: This study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under Asociación de Hemato-Oncología Pediátrica de Centro América (AHOPCA) consortium in Central America. The aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in Central America.

Detailed description: In low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. Without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. Studies have shown that more than half of the children with cancer are also malnourished at diagnosis. This increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. With an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in Central America where the cancer rates and malnutrition is high, as shown by several studies.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of childhood cancer (Solid tumors, Acute Lymphoblastic Leukemia (ALL), other Lymphomas)
* Recruited at diagnosis
* Under the age of 18 years

Exclusion Criteria:

* Other cancer diagnosis
* Palliative care patients

Primary outcomes:
measure: Rate of malnutrition
timeFrame: 3 years
measure: Rate of utilization of nutritional interventions
timeFrame: 3 years
Secondary outcomes:
measure: Cumulative number of grade 3/4 toxicities
timeFrame: 3 years
measure: Survival rate
timeFrame: 3 years
measure: Disease relapse rate
timeFrame: 3 years
measure: Rate of chemotherapy dose reductions
timeFrame: 3 years
measure: Number of treatment delays (in days)
timeFrame: 3 years
measure: Readmission rate
timeFrame: 3 years
measure: Total duration of hospital stay
timeFrame: 3 years
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Oncologia Pediatrica, Hospital Escuela Universitario, Universidad Nacional Autonoma de Honduras
Study officials:
affiliation: Columbia University
name: Elena Ladas, Phd, RD
role: PRINCIPAL_INVESTIGATOR
References: