Hematologic MalignancyNCT04425642
Effects of Parenteral Nutrition in HSCT
A study testing Glucose/Amino acids and Glucose/Amino acids/Lipids in people with Hematologic Malignancy, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Glucose/Amino acids and Glucose/Amino acids/Lipids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2020to 1 Jun 2021
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Autologous HSCT
- Allogeneic HSCT
- Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
- Signed informed consent
- Age > 2 years
Who cannot join
- Secondary HSCT
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pavlov First Saint-Petersburg State Medical University
Saint Petersburg, 197022
About this study
Official title: Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial
Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT
Read the detailed description
The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.
- Conditions
- Hematologic Malignancy
- Being tested
- Glucose/Amino acids, Glucose/Amino acids/Lipids
- Keywords
- HSCT, Parenteral nutrition
- Medical subject headings
- Hematologic Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose/Amino acidsDrug
Also called Aminoplasmal E 15% 500mL glass bottle, Aminoplasmal E 10% 500mL glass bottle, Aminoven infant 10% 100mL glass bottle, Nutriflex 48/150 1000mL polyethylene 2-chamber bag
If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.
Glucose/Amino acids/LipidsDrug
Also called Aminoplasmal E 15% 500mL glass bottle, SMOFlipid 20% 100mL, 250mL, 500mL glass bottle, Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag, Aminoplasmal E 10% 500mL glass bottle
If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Glucose/Amino acids | Experimental | Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight Receives: Drug: Glucose/Amino acids |
| Glucose/Amino acids/Lipids | Experimental | Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight Receives: Drug: Glucose/Amino acids/Lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition
Measured: 60 days
Secondary outcomes (6)
Changes in body weight in HSCT depending on nutritional support approach
Changes in body weight (kg) from baseline to day +30
Measured: 30 days
Changes in body mass index in HSCT depending on nutritional support approach
Changes in body mass index (kg/m^2) from baseline to day +30
Measured: 30 days
Changes in body composition in HSCT depending on nutritional support approach
Changes in body composition via bioimpedance by Tanita bc-418 ma, Japan (total body water (kg), muscle mass (kg), fat (kg)) from baseline to day +30
Measured: 30 days
Changes in resting energy expenditure in HSCT depending on nutritional support approach
Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan)
Measured: 30 days
Severity and duration of anorexia, nausea, vomiting prevention
According CTCAE ver. 5.0, amount and duration of patient's oral food intake
Measured: 60 days
Impact of parenteral nutrition on infection episodes after HSCT
To compare the incidence of sepsis between patients with and without parenteral nutrition. The sepsis criterions are: laboratory tests - positive blood culture, enchanced serum level of C-reactive protein (mg/L) and procalcitonin (mcg/L); clinical signs - fever.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Feb 2020
- Primary completion1 Nov 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Alexander Kulagin, Professor, Study director, Pavlov First Saint Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425642
- Sponsor's protocol ID
- hsct/pn
- Status last verified
- Jun 2021
- First submitted
- 27 May 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04425642
- Acronym / sponsor ID
- hsct/pn
- Conditions
- Hematologic Malignancy
- Keywords
- HSCT, Parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 11 Jun 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.
Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT
Detailed description
The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose/Amino acids | Experimental | Drug: Glucose/Amino acidsPatients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight |
| Glucose/Amino acids/Lipids | Experimental | Drug: Glucose/Amino acids/LipidsPatients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Autologous HSCT
- Allogeneic HSCT
- Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
- Signed informed consent
- Age > 2 years
Key exclusion criteria (1 listed)
- Secondary HSCT
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 |
|---|---|---|
| Glucose/Amino acidsAlso: Aminoplasmal E 15% 500mL glass bottle, Aminoplasmal E 10% 500mL glass bottle, Aminoven infant 10% 100mL glass bottle, Nutriflex 48/150 1000mL polyethylene 2-chamber bagIf indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days. | Drug | Glucose/Amino acids |
| Glucose/Amino acids/LipidsAlso: Aminoplasmal E 15% 500mL glass bottle, SMOFlipid 20% 100mL, 250mL, 500mL glass bottle, Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag, Aminoplasmal E 10% 500mL glass bottleIf indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days. | Drug | Glucose/Amino acids/Lipids |
Primary outcome
Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
Time frame: 60 days
Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition
6 secondary outcomes
Changes in body weight in HSCT depending on nutritional support approach
Time frame: 30 days
Changes in body mass index in HSCT depending on nutritional support approach
Time frame: 30 days
Changes in body composition in HSCT depending on nutritional support approach
Time frame: 30 days
Changes in resting energy expenditure in HSCT depending on nutritional support approach
Time frame: 30 days
Severity and duration of anorexia, nausea, vomiting prevention
Time frame: 60 days
Impact of parenteral nutrition on infection episodes after HSCT
Time frame: 60 days
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 24 Jun 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.
Alexander Kulagin, Professor study director
Pavlov First Saint Petersburg State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose/Amino acids and Glucose/Amino acids/Lipids in people with Hematologic Malignancy, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 5 inclusion and 1 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 24 Jun 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 Russia. 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?
Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0 (time frame: 60 days). 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 24 Jun 2021.