Bone Marrow TransplantationNCT04535570
Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation
An observational study of Bone Marrow Transplantation and Hematopoietic Stem Cell Transplantation, run by Federal University of Minas Gerais at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Indirect Calorimetry
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 31 Mar 2021
- How long will I take part?
- 25 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with hematological disease
- Age equal or superior to 15 years old
- Both sexes
- Will be submitted bone marrow transplantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Enfermagem - UFMG
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: 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.
- Being tested
- Indirect Calorimetry
- Keywords
- Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, Indirect Calorimetry, Energy Metabolism, Basal Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre Transplant | All 20 patients will have the energy expenditure measured in the pre-transplantation in order to compare with post-transplant data. Receives: 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. Receives: Other: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks after protocol termination
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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
Measured: Up to 3 weeks after protocol termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2018
- Primary completion1 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 25 Days
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Simone V Generoso, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535570
- Sponsor's protocol ID
- 58010016.0.0000.5149
- Status last verified
- Aug 2021
- First submitted
- 13 Jun 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation in Patients With Hematological Disease and Associated Factors
- ClinicalTrials.gov ID
- NCT04535570
- Acronym / sponsor ID
- 58010016.0.0000.5149
- Keywords
- Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, Indirect Calorimetry, Energy Metabolism, Basal Metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 25 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Transplant | – | Other: Indirect CalorimetryAll 20 patients will have the energy expenditure measured in the pre-transplantation in order to compare with post-transplant data. |
| Post Transplant | – | Other: Indirect CalorimetryAll 20 patients will have the energy expenditure measured in the post transplantation in order to compare with the pre-transplant data. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients with hematological disease
- Age equal or superior to 15 years old
- Both sexes
- Will be submitted bone marrow transplantation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryIn 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. | Other | Post Transplant, Pre Transplant |
Primary outcome
Energy expenditure
Time frame: 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.
3 secondary outcomes
Nutritional status of patients
Time frame: Up to 3 weeks after protocol termination
Caloric and protein adequacy
Time frame: Up to 3 weeks after protocol termination
Clinical outcomes
Time frame: Up to 3 weeks after protocol termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone V Generoso principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplantation and Hematopoietic Stem Cell Transplantation, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: Up to 3 weeks after protocol termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.