Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay
NCT ID: NCT04240600
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
74 participants
INTERVENTIONAL
2020-12-01
2021-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
Experimental group
2 cans or bottles (200ml)per day, orally
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).
Control group
2 cans or bottles (200ml)per day, orally
Interventions
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Experimental group
2 cans or bottles (200ml)per day, orally
Control group
2 cans or bottles (200ml)per day, orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Hospital General de Mexico
OTHER_GOV
Responsible Party
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Dr. Vanessa Fuchs Tarlovsky
Principal Investigator
Principal Investigators
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Vanessa Fuchs Tarlovsky, PhD
Role: STUDY_DIRECTOR
Hospital General de México
Locations
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Vannesa Fuchs Tarlovsky
Mexico City, , Mexico
Hospital General de México
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Monica P Bejarano, MSc
Role: primary
Other Identifiers
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DI/19/11/03/017
Identifier Type: -
Identifier Source: org_study_id
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