Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Other: Indirect Calorimetry

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30130-100
      • Escola de Enfermagem - UFMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients of both sexes, older than 15 years old, hospitalized in the Bone Marrow Transplant sector of the Hospital das Clínicas of the Federal University of Minas Gerais and submitted to transplantation will be evaluated.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre Transplant; All 20 patients will have the energy expenditure measured in the pre-transplantation in order to compare with post-transplant data.	Other: Indirect Calorimetry; 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.
Post Transplant; All 20 patients will have the energy expenditure measured in the post transplantation in order to compare with the pre-transplant data.	Other: Indirect Calorimetry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure	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.	Up to 3 weeks after protocol termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status of patients	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.	Up to 3 weeks after protocol termination
Caloric and protein adequacy	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)	Up to 3 weeks after protocol termination
Clinical outcomes	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	Up to 3 weeks after protocol termination

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Simone V Generoso, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (ACTUAL): September 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation; Energy Metabolism; Indirect Calorimetry; Basal Metabolism
• Other Study ID Numbers: 58010016.0.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No