NCT04240600

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

January 22, 2020

Last Update Submit

September 2, 2020

Conditions

Acute Myeloid Leukemia, Adult

Keywords

nutritionacute myeloid leukemiabody compositionchemotherapy recoveryVEGF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Body composition fat mass

    21 days

  • Body compositition: fat-free mass

    21 days

  • Body composition: phase angle

    21 days

  • SARC-F

    21 days

  • Length of stay

    It depends of the patients health condition

  • +7 more secondary outcomes

Study Arms (2)

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).

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).

Dietary Supplement: Control group

Interventions

Experimental groupDIETARY_SUPPLEMENT

2 cans or bottles (200ml)per day, orally

Also known as: Supportan DKN
Hyperproteic, hypercaloric formula
Control groupDIETARY_SUPPLEMENT

2 cans or bottles (200ml)per day, orally

Also known as: Fresubin® Original DRINK
Standard formula

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vannesa Fuchs Tarlovsky

Mexico City, 06720, Mexico

RECRUITING

Hospital General de México

Mexico City, 06726, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Vanessa Fuchs Tarlovsky, PhD

    Hospital General de México

    STUDY DIRECTOR

Central Study Contacts

Vanessa Fuchs Tarlovsky, PhD

CONTACT

+52 27 89 20 00vanessafuchstarlovsky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized clinical trial study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

December 1, 2020

Primary Completion

January 1, 2021

Study Completion

December 1, 2021

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

ME(2)