Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535570
• Other study ID #: 58010016.0.0000.5149
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Hematopoietic Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
Brazil	Escola de Enfermagem - UFMG	Belo Horizonte	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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