Acute Myeloid Leukemia, AdultHEMVEFNCT04240600
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay
A study testing Experimental group in people with Acute Myeloid Leukemia, Adult, run by Hospital General de Mexico at 2 sites in Mexico.
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- Experimental group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Dec 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
Vannesa Fuchs Tarlovsky
Mexico City, 06720
Monica P Bejarano, MSc, +525527027026
- Not yet recruiting
Hospital General de México
Mexico City, 06726
Vanessa Fuchs, PhD, 551 85331635, vanessafuchs@hotmail.com
Karolina Alvarez- Altamirano, MSc
About this study
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
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 .
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- Experimental group, Control group
- Keywords
- nutrition, acute myeloid leukemia, body composition, chemotherapy recovery, VEGF
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDietary supplement
Also called Supportan DKN
2 cans or bottles (200ml)per day, orally
Control groupDietary supplement
Also called Fresubin® Original DRINK
2 cans or bottles (200ml)per day, orally
| Study group | Role | What they receive |
|---|---|---|
| Hyperproteic, hypercaloric formula | Experimental | Each patient will receive 2 bottles per day of Supportan DKN during the hospital stay (nutritional contribution: 600 kcal and 40 g of protein). Receives: Dietary Supplement: Experimental group |
| Standard formula | Active comparator | 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). Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (12)
Body composition fat mass
To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Measured: 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.
Measured: 21 days
Body composition: phase angle
To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy.
Measured: 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.
Measured: 21 days
Length of stay
To evaluate the length of stay (in days) of their induction chemotherapy recovery
Measured: It depends of the patients health condition
Early mortality
Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment
Measured: 21 days
Late mortality
Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy
Measured: 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
Measured: 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.
Measured: 21 days
Levels of VEGF
To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment
Measured: 2 years
Response to induction chemotherapy.
To evaluate response to induction chemotherapy from to blast citometry percentaje
Measured: 28 days
Early biochemical recovery values
To evaluate the recovery of platelets, neutrophils, hemoglobin
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico
- Investigators
- Vanessa Fuchs Tarlovsky, PhD, Study director, Hospital General de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240600
- Sponsor's protocol ID
- DI/19/11/03/017
- Acronym
- HEMVEF
- Status last verified
- Sep 2020
- First submitted
- 22 Jan 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04240600
- Acronym / sponsor ID
- HEMVEF / DI/19/11/03/017
- Conditions
- Acute Myeloid Leukemia, Adult
- Keywords
- nutrition, acute myeloid leukemia, body composition, chemotherapy recovery, VEGF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Collaborators
- Fresenius Kabi
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized clinical trial study
| Arm | Type | Receives |
|---|---|---|
| Hyperproteic, hypercaloric formula | Experimental | Dietary Supplement: Experimental groupEach patient will receive 2 bottles per day of Supportan DKN during the hospital stay (nutritional contribution: 600 kcal and 40 g of protein). |
| Standard formula | Active comparator | Dietary Supplement: Control groupEach patient will receive 2 cans or bottles per day of Fresubin® Original DRINK (nutritional contribution: 474.2 kcal and 17.6 g of protein). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Geriatric patients (> 60 years)
- Patients with acute gastrointestinal bleeding, ileus and shock
- History of recurrence of neoplasm
- Renal failure
- Atrophy of the gastrointestinal mucosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: Supportan DKN2 cans or bottles (200ml)per day, orally | Dietary supplement | Hyperproteic, hypercaloric formula |
| Control groupAlso: Fresubin® Original DRINK2 cans or bottles (200ml)per day, orally | Dietary supplement | Standard formula |
Primary outcome
Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
Time frame: 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.
12 secondary outcomes
Body composition fat mass
Time frame: 21 days
Body compositition: fat-free mass
Time frame: 21 days
Body composition: phase angle
Time frame: 21 days
SARC-F
Time frame: 21 days
Length of stay
Time frame: It depends of the patients health condition
Early mortality
Time frame: 21 days
Late mortality
Time frame: 1 year
Changes in nutritional status during oncological therapy
Time frame: 21 days
Evaluation of the quality of life at the beginning and after the intervention.
Time frame: 21 days
Levels of VEGF
Time frame: 2 years
Response to induction chemotherapy.
Time frame: 28 days
Early biochemical recovery values
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Fuchs Tarlovsky, PhD study director
Hospital General de México
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Acute Myeloid Leukemia, Adult, run by Hospital General de Mexico at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Fuchs Tarlovsky, PhD (+52 27 89 20 00 ext. 1453, vanessafuchstarlovsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.