Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay

Study Overview
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Brief Summary
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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 .

Detailed Description
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Patients with acute myeloid leukemia have a high risk of suffering sarcopenia, which decreases the oncology therapy clinical response, functional ability and quality of life. Chemotherapy is used in these patients, some of them inhibit angiogenesis and act in an important way in physiological processes of muscle anabolism. The vascular endothelial growth factor (VEGF) and its receptors (VEGFR) play a crucial role in both normal and malignant angiogenesis. Activation of the VEGF pathway leads to endothelial cell activation, proliferation and survival. The objective of this study is to compare the effect of the use of a high protein, high energy enteral with omega 3 formula (Supportan DKN) against a standard enteral formula (Fresubin® Original DRINK) on body composition, days of hospital stay, quality of life, associated muscular strength with levels of VEGF in patients with acute myeloid leukemia during induction chemotherapy. An open clinical trial was designed, in which a group of patients will receive, as part of their nutritional requirements a hyperproteic hyperenergetic enteral formula versus standard formula during the 21 days of the first cycle of antineoplastic treatment. We will measure body composition, muscle strength and serum concentrations of VEGFR in both groups to be able to compare its effect.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Adult

Intervention / Treatment
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* Dietary Supplement: Experimental group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperproteic, hypercaloric formula<br>Each patient will receive 2 bottles per day of Supportan DKN during the hospital stay (nutritional contribution: 600 kcal and 40 g of protein). | Dietary Supplement: Experimental group<br>* 2 cans or bottles (200ml)per day, orally<br>* Other names: Supportan DKN;|
| Active Comparator: Standard formula<br>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). | Dietary Supplement: Control group<br>* 2 cans or bottles (200ml)per day, orally<br>* Other names: Fresubin® Original DRINK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF | The aim of this study is to compare the effect of the use of a hyperproteic hypercaloric enteral formula (Supportan DKN.) With a standard enteral formula (Fresubin® Original DRINK) in patients with AML during antineoplastic treatment. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition fat mass | To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy. | 21 days | 
| Body compositition: fat-free mass | To messured fat-free mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy. | 21 days | 
| Body composition: phase angle | To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy. | 21 days | 
| SARC-F | To evaluate the score of SARC-F (an scale of symptoms to predict patients with sarcopenia at risk of low functional outcome) at the beginning and after intervention therapy. | 21 days | 
| Length of stay | To evaluate the length of stay (in days) of their induction chemotherapy recovery | It depends of the patients health condition | 
| Early mortality | Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment | 21 days | 
| Late mortality | Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy | 1 year | 
| Changes in nutritional status during oncological therapy | To documented in text format presence of changes in nutritional status according biochemical,clinical and anthropometric paramethers . This changes will be evaluated by a standarized nutricionist acording ESPEN guideliness for oncological patients | 21 days | 
| Evaluation of the quality of life at the beginning and after the intervention. | To evaluate the score of the European Organization for Research and Treatment of Cancer (EORTC) at the beginning and after intervention therapy. | 21 days | 
| Levels of VEGF | To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment | 2 years | 
| Response to induction chemotherapy. | To evaluate response to induction chemotherapy from to blast citometry percentaje | 28 days | 
| Early biochemical recovery values | To evaluate the recovery of platelets, neutrophils, hemoglobin | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, acute myeloid leukemia, body composition, chemotherapy recovery, VEGF