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

Acute Myeloid Leukemia, Adult Clinical Trial

— HEMVEF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240600
• Other study ID #: DI/19/11/03/017
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2020
• Source: Hospital General de Mexico
• Contact: Vanessa Fuchs Tarlovsky, PhD
• Phone: +52 27 89 20 00
• Email: vanessafuchstarlovsky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Dietary Supplement:
• Experimental group
2 cans or bottles (200ml)per day, orally
• Control group
2 cans or bottles (200ml)per day, orally

Locations

Country	Name	City	State
Mexico	Hospital General de México	Mexico City
Mexico	Vannesa Fuchs Tarlovsky	Mexico city

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General de Mexico	Fresenius Kabi

Country where clinical trial is conducted

Mexico, 

Outcome

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