Clinical trial · Interventional
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition, Muscle Strength and Concentration of Vascular Endothelial Growth Factor (VEGF) in Patients With Actue Myeloid Leukemia (AML) During the Hospital Stay
NCT04240600CI-TRIAL-00046942HEMVEFunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Dietary Supplement | — | UNRESOLVED |
| Experimental group | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperproteic, hypercaloric formula
- description
- Each patient will receive 2 bottles per day of Supportan DKN during the hospital stay (nutritional contribution: 600 kcal and 40 g of protein).
- interventionNames
- Dietary Supplement: Experimental group
- type
- ACTIVE_COMPARATOR
- label
- Standard formula
- description
- Each patient will receive 2 cans or bottles per day of Fresubin® Original DRINK (nutritional contribution: 474.2 kcal and 17.6 g of protein).
- interventionNames
- Dietary Supplement: Control group
Primary outcomes (1)
- measure
- Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a confirmed diagnosis of AML * Tolerance to oral feeding * Induction Chemotherapy * Patients with nutritional risk of positive malnutrition (Score +3 NRS). * Candidates to receive enteral nutrition, as well as chemotherapy according to medical indications. * Life expectancy greater than a week and with the possibility of starting oncological treatment. Have informed consent obtained by the patient prior to randomization Exclusion Criteria: * Geriatric patients (\> 60 years) * Patients with acute gastrointestinal bleeding, ileus and shock * History of recurrence of neoplasm * Renal failure * Atrophy of the gastrointestinal mucosa * Central nervous system disease, * impaired cardiac function. Elimination criteria: Lack of follow up Incomplete data. Insufficient amount of genetic material to perform the determination of the VEGF material. Absence of the determination of the levels of VEGF prior to the start of oncological therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.