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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04535570
Enrollment
20
Registered
2020-09-02
Start date
2018-10-01
Completion date
2021-03-31
Last updated
2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation

Keywords

Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, Indirect Calorimetry, Energy Metabolism, Basal Metabolism

Brief summary

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.

Interventions

OTHERIndirect 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.

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Energy expenditureUp to 3 weeks after protocol terminationThe 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

MeasureTime frameDescription
Nutritional status of patientsUp to 3 weeks after protocol terminationWe'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.
Caloric and protein adequacyUp to 3 weeks after protocol terminationThe 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)
Clinical outcomesUp to 3 weeks after protocol terminationPatients 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026