Nutrition in Pediatric Oncology in Central America

Nutrition in Cancer Survival and Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976830
• Other study ID #: AAAS1869
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: June 2019
• Source: Columbia University
• Contact: Elena Ladas, Phd, RD
• Phone: 212-305-7835
• Email: ejd14[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrition in Cancer Survival and Treatment

Locations

Country	Name	City	State
Honduras	Oncologia Pediatrica, Hospital Escuela Universitario, Universidad Nacional Autonoma de Honduras	Tegucigalpa

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Hospital Escuela Universitario, Honduras

Country where clinical trial is conducted

Honduras, 

Outcome

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