Nutrition in Pediatric Oncology in Central America

The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Central America

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.

Study Overview

• Status: Unknown
• Conditions: Nutrition in Cancer Survival and Treatment

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Suvekshya Aryal, MPH; Phone Number: 646-317-2070; Email: sa3234@cumc.columbia.edu
• Study Contact Backup: Name: Elena Ladas, PhD, RD; Phone Number: 212-305-7835; Email: ejd14@cumc.columbia.edu

Study Locations

• Honduras
  • Tegucigalpa, Honduras
    • Recruiting
    • Oncologia Pediatrica, Hospital Escuela Universitario, Universidad Nacional Autonoma de Honduras
    • Contact: Stephany Zelaya, RD; Email: steph_sazel@hotmail.com
    • Principal Investigator: Armando Peña-Hernandez, MD
    • Sub-Investigator: Stephany Zelaya, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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. Patients will be recruited and consented (including parents) by a designated researcher. Demographics is collected from medical records, and other required data will be collected from charts and/or assessed by designated researcher or clinician. Accrual is anticipated to take place over a 3-year period. All data collection will occur on routine clinical visits or during hospitalization, as per treatment protocol, not requiring otherwise unscheduled visits to the hospital. Determination of time-points coincides with variations in therapy as per the treatment protocols followed by the hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children diagnosed with cancer; Patients diagnosed with childhood cancer in participating sites in Central American countries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of malnutrition	Determine the change in malnutrition by comparing nutritional status measured by anthropometric data at diagnosis and during and end of treatment.	3 years
Rate of utilization of nutritional interventions	Impact on the delivery of nutritional services, defined as utilization of nutritional interventions. Information on utilization of nutritional services will be collected on a medical nutrition support (MNS) case report form, which collects information on the provision of enteral feeds (nasogastric feeds, gastrostomy feeds), oral nutrition supplements (e.g. Pediasure®, Ensure®) and days of total parenteral nutrition (TPN) over the previous phase of treatment. The MNS form also provides information on the brand of nutritional formula and the prescribed dose (i.e. amount in grams of supplement per day). If enteral feeds are administered, the formula, rate, and duration are reported. The responses collected on the MNS form will be used to determine the rate of utilization of nutritional interventions.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 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).	3 years
Disease relapse rate	Investigate the association of nutritional status and disease relapse	3 years
Rate of chemotherapy dose reductions	The rate of chemotherapy dose reductions will be measured.	3 years
Number of treatment delays (in days)	The number of treatment delays will be measured in days.	3 years
Readmission rate	The readmission rate will be measured by the number of readmissions.	3 years
Total duration of hospital stay	The total duration of hospital stay will be measured in days.	3 years

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Hospital Escuela Universitario, Honduras
• Investigators: Principal Investigator: Elena Ladas, PhD, RD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Childhood Cancer; Malnutrition; Central America
• Other Study ID Numbers: AAAS1869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No