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NCT Number: NCT04535570

Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

The treatment before bone marrow transplantantion is initiated by chemotherapy associated or not with radiotherapy, both of which cause various side effects on the patient as symptoms that impair food intake. The nutritional status of the patient is one of the factors related to the success of the transplant, so a complete nutritional assessment before transplantation is necessary in order to identify patients at nutritional risk, nutritional disorders and to perform appropriate and early intervention to promote recovery and / or health maintenance. Will be used for nutritional assessment: arm perimeter, arm muscle area; electrical bioimpedance, phase angle, and Indirect Calorimetry, a standard method of noninvasive nutritional assessment that expresses the nutritional demand and rate of utilization of energy substrates from oxygen consumption and carbon dioxide production through the air inhaled and exhaled by the individual's lungs.

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Key information

Conditions

Bone Marrow Transplantation Hematopoietic Stem Cell Transplantation

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hematological disease
  • Age equal or superior to 15 years old
  • Both sexes
  • Will be submitted bone marrow transplantation

Exclusion criteria

  • Age below 15 years old
  • Those who can't perform calorimetry (oxygen therapy, mechanical ventilation)
  • Have hyper or hypothyroidism
  • Admitted to the Intensive Care Unit (without at least one result of post-transplant indirect calorimetry)
  • Don't agree to participate in the study

Treatment and study plan

Indirect Calorimetry

Other

In the pre-transplant, before the conditioning regime, and also on the 10th and 17th post-transplant, the resting energy expenditure was measured by indirect calorimetry.

Primary outcomes

  1. Energy expenditure

    Time frame: Up to 3 weeks after protocol termination

    The energy expenditure will be analyzed by the volume of oxygen (VO2) consumed, the volume of carbon dioxide (VCO2) produced and the respiratory quotient (VO2 / VCO2). The values analyzed will be the results of the measures of energy expenditure (BMR) before and after the transplant, in calories (Kcal), to verify changes caused by chemotherapy and / or radiation therapy.

Secondary outcomes

  1. Nutritional status of patients

    Time frame: Up to 3 weeks after protocol termination

    We'll use ASG for this parameter. Patients will have nutritional status classified as malnourished, nourished or overweight, in the periods before and after transplantation to verify changes caused by chemotherapy and / or radiation therapy.

  2. Caloric and protein adequacy

    Time frame: Up to 3 weeks after protocol termination

    The caloric and protein adequacy will be analyzed by the amount of calorie (kcal / kg / day) and protein (g / kg / day) intake, compared to calorie and protein required before and after transplantation, to verify changes caused by chemotherapy and / or radiation therapy.The caloric and protein adequacy will be presented with g/kg/day (protein) or kcal/kg/day (calories)

  3. Clinical outcomes

    Time frame: Up to 3 weeks after protocol termination

    Patients will have the following outcomes:

    • constipation or diarrhea - Bristol stool scale pontuation (7 points scale)
    • mucositis (grade I-IV) - Dentistry report with grade of mucositis in grade I,II,III or IV
    • graft versus host disease (grade I-IV) - Medical report with grade of GVHD in grade I, II, III or IV
    • presence of Cytomegalovirus infection - Blood test Positive or Negative
    • colonization of Clostridium difficile - Feces Test Positive or Negative
    • infection by Candida - Laboratory test positive or negative
    • another diagnosis of infection - Medical report/ Yes or no for presence of this complication
    • presence of febrile neutropenia - Medical report / Yes or no for presence of this complication
    • length of hospital stay - number of complete days of hospitalization
    • death during the hospital stay - number of death during hospitalization

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation in Patients With Hematological Disease and Associated Factors

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 2, 2020
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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