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

September 2, 2020 updated by: Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico City, Mexico, 06726
        • Not yet recruiting
        • Hospital General de Mexico
        • Contact:
        • Sub-Investigator:
          • Karolina Alvarez- Altamirano, MSc
        • Sub-Investigator:
          • Erika Rosas- Gonzalez, MD
        • Sub-Investigator:
          • Monica Bejarano- Rosales, MSc
        • Sub-Investigator:
          • Christian Ramos- Peñafiel, PhD
      • Mexico city, Mexico, 06720
        • Recruiting
        • Vannesa Fuchs Tarlovsky
        • Contact:
          • Monica P Bejarano, MSc
          • Phone Number: +525527027026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hyperproteic, hypercaloric formula
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
2 cans or bottles (200ml)per day, orally
Other Names:
  • Supportan DKN
ACTIVE_COMPARATOR: Standard formula
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
2 cans or bottles (200ml)per day, orally
Other Names:
  • Fresubin® Original DRINK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
Time Frame: 21 days
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
Time Frame: 21 days
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
Time Frame: 21 days
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
Time Frame: 21 days
To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
21 days
SARC-F
Time Frame: 21 days
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
Time Frame: It depends of the patients health condition
To evaluate the length of stay (in days) of their induction chemotherapy recovery
It depends of the patients health condition
Early mortality
Time Frame: 21 days
Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment
21 days
Late mortality
Time Frame: 1 year
Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy
1 year
Changes in nutritional status during oncological therapy
Time Frame: 21 days
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.
Time Frame: 21 days
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
Time Frame: 2 years
To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment
2 years
Response to induction chemotherapy.
Time Frame: 28 days
To evaluate response to induction chemotherapy from to blast citometry percentaje
28 days
Early biochemical recovery values
Time Frame: 28 days
To evaluate the recovery of platelets, neutrophils, hemoglobin
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Mexico

Collaborators

Fresenius Kabi

Investigators

  • Study Director: Vanessa Fuchs Tarlovsky, PhD, Hospital General de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI/19/11/03/017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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