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

Hospital General de Mexico

Status: Unknown

Conditions: Acute Myeloid Leukemia, Adult

Treatments: Dietary Supplement: Control group; Dietary Supplement: Experimental group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04240600

DI/19/11/03/017

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Hyperproteic, hypercaloric formula

Experimental group

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).

Treatment:

Dietary Supplement: Experimental group

Standard formula

Active Comparator group

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).

Treatment:

Dietary Supplement: Control group