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

Last updated: September 2, 2020
Sponsor: Hospital General de Mexico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT04240600
DI/19/11/03/017
  • Ages 18-60
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

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 medicalindications.

  • Life expectancy greater than a week and with the possibility of starting oncologicaltreatment. Have informed consent obtained by the patient prior to randomization

Exclusion

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 thedetermination of the VEGF material. Absence of the determination of the levels of VEGF prior to the start of oncologicaltherapy.

Study Design

Total Participants: 74
Study Start date:
December 01, 2020
Estimated Completion Date:
December 01, 2021

Study 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.

Connect with a study center

  • Hospital General de México

    Mexico City, 06726
    Mexico

    Site Not Available

  • Vannesa Fuchs Tarlovsky

    Mexico city, 06720
    Mexico

    Active - Recruiting

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