Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Completed
CT.gov ID
NCT04535570
Collaborator
(none)
20
1
30
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Indirect Calorimetry

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation in Patients With Hematological Disease and Associated Factors
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Energy expenditure [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 Outcome Measures

  1. Nutritional status of patients [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Escola de Enfermagem - UFMG Belo Horizonte MG Brazil 30130-100

Sponsors and Collaborators

  • Federal University of Minas Gerais

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Isabel Toulson Davisson Correia, Principal investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT04535570
Other Study ID Numbers:
  • 58010016.0.0000.5149
First Posted:
Sep 2, 2020
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Isabel Toulson Davisson Correia, Principal investigator, Federal University of Minas Gerais

Study Results

No Results Posted as of Aug 23, 2021