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

Sponsor

Hospital General de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04240600

Collaborator

Fresenius Kabi (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia, Adult	Dietary Supplement: Experimental group Dietary Supplement: Control group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized clinical trial studyA randomized clinical trial study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF [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.

Secondary Outcome Measures

Body composition fat mass [21 days]
To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Body compositition: fat-free mass [21 days]
To messured fat-free mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Body composition: phase angle [21 days]
To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
SARC-F [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.
Length of stay [It depends of the patients health condition]
To evaluate the length of stay (in days) of their induction chemotherapy recovery
Early mortality [21 days]
Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment
Late mortality [1 year]
Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy
Changes in nutritional status during oncological therapy [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
Evaluation of the quality of life at the beginning and after the intervention. [21 days]
To evaluate the score of the European Organization for Research and Treatment of Cancer (EORTC) at the beginning and after intervention therapy.
Levels of VEGF [2 years]
To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment
Response to induction chemotherapy. [28 days]
To evaluate response to induction chemotherapy from to blast citometry percentaje
Early biochemical recovery values [28 days]
To evaluate the recovery of platelets, neutrophils, hemoglobin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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