Clinical trial NCT04240600: Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia, Adult
Keywords: nutrition
acute myeloid leukemia
body composition
chemotherapy recovery
VEGF
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Fresenius Kabi
First posted: 2020-01-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
timeFrame: 21 days
Secondary outcomes:
measure: Body composition fat mass
timeFrame: 21 days
measure: Body compositition: fat-free mass
timeFrame: 21 days
measure: Body composition: phase angle
timeFrame: 21 days
measure: SARC-F
timeFrame: 21 days
measure: Length of stay
timeFrame: It depends of the patients health condition
measure: Early mortality
timeFrame: 21 days
measure: Late mortality
timeFrame: 1 year
measure: Changes in nutritional status during oncological therapy
timeFrame: 21 days
measure: Evaluation of the quality of life at the beginning and after the intervention.
timeFrame: 21 days
measure: Levels of VEGF
timeFrame: 2 years
measure: Response to induction chemotherapy.
timeFrame: 28 days
measure: Early biochemical recovery values
timeFrame: 28 days
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Vannesa Fuchs Tarlovsky
city: Mexico City
country: Mexico
facility: Hospital General de México
Study officials:
affiliation: Hospital General de México
name: Vanessa Fuchs Tarlovsky, PhD
role: STUDY_DIRECTOR
References: