- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031586
Delivery of Nutritional Services in Nicaragua
July 22, 2019 updated by: Elena Ladas, Columbia University
The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer 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.
Study Overview
Status
Recruiting
Conditions
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)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elena Ladas, PhD, RD
- Phone Number: 212-305-7835
- Email: ejd14@cumc.columbia.edu
Study Contact Backup
- Name: Evelyn Paulino, MS, RDN
- Phone Number: 212.342.0262
- Email: ep2965@cumc.columbia.edu
Study Locations
-
-
-
Managua, Nicaragua
- Recruiting
- Children's Hospital Manuel de Jesus Rivera (CHMJR)
-
Contact:
- Roberta Ortiz, MD
- Email: dra.robertaortiz72@yahoo.com
-
Contact:
- Maria de Los Angeles
- Email: carrillomaria436@gmail.com
-
Principal Investigator:
- Roberta Ortiz, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
Children diagnosed with solid tumors in Children's Hospital Manuel de Jesus Rivera (CHMJR) in Nicaragua will be recruited at diagnosis.
A total of 300 patients are anticipated for the study in AHOPCA affiliated institution.
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 the 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:
- Recent diagnosis of childhood cancer (Solid Tumors)
- Recruited at diagnosis
- Under the age of 18 years
Exclusion Criteria:
- Other cancer diagnosis
- Palliative care patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Children diagnosed with Solid Tumors
Children diagnosed with solid tumors in Managua, Nicaragua in Central America
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 3 years
|
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).
|
Up to 3 years
|
Disease relapse rate
Time Frame: Up to 3 years
|
Investigate the association of nutritional status and disease relapse
|
Up to 3 years
|
Rate of chemotherapy dose reductions
Time Frame: Up to 3 years
|
The rate of chemotherapy dose reductions will be measured.
|
Up to 3 years
|
Number of treatment delays (in days)
Time Frame: Up to 3 years
|
The number of treatment delays will be measured in days
|
Up to 3 years
|
Total duration of hospital stay
Time Frame: Up to 3 years
|
The total duration of hospital stay will be measured in days.
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elena Ladas, PhD, RD, Columbia University
- Principal Investigator: Roberta Ortiz, MD, Children's Hospital Manuel de Jesus Rivera (CHMJR)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2018
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
July 22, 2019
First Submitted That Met QC Criteria
July 22, 2019
First Posted (Actual)
July 24, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- AAAR7379
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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