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Completed

NCT Number: NCT04031586

Delivery of Nutritional Services in Nicaragua

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.

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Key information

Conditions

Nutrition in Cancer Survival and Treatment Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Manuel de Jesus Rivera (CHMJR)

Managua, Nicaragua

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recent diagnosis of childhood cancer (Solid Tumors)
  • Recruited at diagnosis
  • Under the age of 18 years

Exclusion criteria

  • Other cancer diagnosis
  • Palliative care patients

Treatment and study plan

Primary outcomes

  1. Rate of malnutrition

    Time frame: Up to 3 years

    Determine the change in malnutrition by comparing nutritional status measured by anthropometric data at diagnosis and during and end of treatment.

  2. Rate of utilization of nutritional interventions

    Time frame: Up to 3 years

    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.

Secondary outcomes

  1. Cumulative number of grade 3/4 toxicities

    Time frame: Up to 3 years

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

  2. Survival rate

    Time frame: Up to 3 years

    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. Disease relapse rate

    Time frame: Up to 3 years

    Investigate the association of nutritional status and disease relapse

  4. Rate of chemotherapy dose reductions

    Time frame: Up to 3 years

    The rate of chemotherapy dose reductions will be measured.

  5. Number of treatment delays (in days)

    Time frame: Up to 3 years

    The number of treatment delays will be measured in days

  6. Total duration of hospital stay

    Time frame: Up to 3 years

    The total duration of hospital stay will be measured in days.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2019
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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