Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

NCT04535570 | Completed DMC

• 1 other identifier: 58010016.0.0000.5149
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Nutritional status of patients

  Up to 3 weeks after protocol termination

• Caloric and protein adequacy

  Up to 3 weeks after protocol termination

• Clinical outcomes

  Up to 3 weeks after protocol termination

Study Arms (2)

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

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

Interventions

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.

Post Transplant; Pre Transplant

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

MeSH Terms

Interventions

Calorimetry, Indirect

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Simone V Generoso

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: September 2, 2020
• Study Start: October 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: March 31, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)