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 .
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
2 cans or bottles (200ml)per day, orally
2 cans or bottles (200ml)per day, orally
Vannesa Fuchs Tarlovsky
Mexico City, Mexico
RECRUITINGHospital General de México
Mexico City, Mexico
NOT_YET_RECRUITINGEffect 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.
Time frame: 21 days
Body composition fat mass
To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Time frame: 21 days
Body compositition: fat-free mass
To messured fat-free mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Time frame: 21 days
Body composition: phase angle
To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Time frame: 21 days
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.
Time frame: 21 days
Length of stay
To evaluate the length of stay (in days) of their induction chemotherapy recovery
Time frame: It depends of the patients health condition
Early mortality
Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment
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Time frame: 21 days
Late mortality
Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy
Time frame: 1 year
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
Time frame: 21 days
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.
Time frame: 21 days
Levels of VEGF
To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment
Time frame: 2 years
Response to induction chemotherapy.
To evaluate response to induction chemotherapy from to blast citometry percentaje
Time frame: 28 days
Early biochemical recovery values
To evaluate the recovery of platelets, neutrophils, hemoglobin
Time frame: 28 days