Nutrition in Cancer Survival and TreatmentNCT04031586
Delivery of Nutritional Services in Nicaragua
An observational study of Nutrition in Cancer Survival and Treatment, run by Columbia University at 1 site in Nicaragua.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nutrition in Cancer Survival and Treatment
- How many people
- 50 participants
- Where
- 1 siteNicaragua
- Study dates
- 5 Nov 2018to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Recent diagnosis of childhood cancer (Solid Tumors)
- Recruited at diagnosis
- Under the age of 18 years
Who cannot join
- Other cancer diagnosis
- Palliative care patients
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Children's Hospital Manuel de Jesus Rivera (CHMJR)
Managua
About this study
Official title: 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.
Read the 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.
- Keywords
- Malnutrition, Childhood Cancer, Central America, Nicaragua
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with Solid Tumors | Children diagnosed with solid tumors in Managua, Nicaragua in Central America |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of malnutrition
Determine the change in malnutrition by comparing nutritional status measured by anthropometric data at diagnosis and during and end of treatment.
Measured: Up to 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.
Measured: Up to 3 years
Secondary outcomes (6)
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).
Measured: Up to 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).
Measured: Up to 3 years
Disease relapse rate
Investigate the association of nutritional status and disease relapse
Measured: Up to 3 years
Rate of chemotherapy dose reductions
The rate of chemotherapy dose reductions will be measured.
Measured: Up to 3 years
Number of treatment delays (in days)
The number of treatment delays will be measured in days
Measured: Up to 3 years
Total duration of hospital stay
The total duration of hospital stay will be measured in days.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start5 Nov 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition in Cancer Survival and TreatmentStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Ladas, Phd, RD, Principal investigator, Columbia UniversityRoberta Ortiz, MD, Principal investigator, Children's Hospital Manuel de Jesus Rivera (CHMJR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031586
- Sponsor's protocol ID
- AAAR7379
- Status last verified
- May 2024
- First submitted
- 22 Jul 2019
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Nicaragua
- ClinicalTrials.gov ID
- NCT04031586
- Acronym / sponsor ID
- AAAR7379
- Keywords
- Malnutrition, Childhood Cancer, Central America, Nicaragua
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with Solid Tumors | – | –Children diagnosed with solid tumors in Managua, Nicaragua in Central America |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Recent diagnosis of childhood cancer (Solid Tumors)
- Recruited at diagnosis
- Under the age of 18 years
Key exclusion criteria (2 listed)
- Other cancer diagnosis
- Palliative care patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
6 secondary outcomes
Cumulative number of grade 3/4 toxicities
Time frame: Up to 3 years
Survival rate
Time frame: Up to 3 years
Disease relapse rate
Time frame: Up to 3 years
Rate of chemotherapy dose reductions
Time frame: Up to 3 years
Number of treatment delays (in days)
Time frame: Up to 3 years
Total duration of hospital stay
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Ladas, Phd, RD principal investigator
Columbia University
Roberta Ortiz, MD principal investigator
Children's Hospital Manuel de Jesus Rivera (CHMJR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition in Cancer Survival and Treatment, run by Columbia University at 1 site in Nicaragua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nicaragua. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of malnutrition (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.