Acute Myeloid Leukemia, Adult
Conditions
Keywords
nutrition, acute myeloid leukemia, body composition, chemotherapy recovery, VEGF
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 .
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.
Interventions
DIETARY_SUPPLEMENTExperimental group
2 cans or bottles (200ml)per day, orally
DIETARY_SUPPLEMENTControl group
2 cans or bottles (200ml)per day, orally
Sponsors
Fresenius Kabi
Hospital General de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A randomized clinical trial study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Body composition fat mass | 21 days | To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy. |
| 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 |
| Late mortality | 1 year | Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy |
Countries
Mexico
Contacts
Primary ContactVanessa Fuchs Tarlovsky, PhD
Outcome results
None listed