<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04425642</url>
  </required_header>
  <id_info>
    <org_study_id>hsct/pn</org_study_id>
    <nct_id>NCT04425642</nct_id>
  </id_info>
  <brief_title>Effects of Parenteral Nutrition in HSCT</brief_title>
  <official_title>Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Petersburg State Pavlov Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Petersburg State Pavlov Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have&#xD;
      undergone changes recently due to new conditioning regimen and graft versus disease&#xD;
      prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition&#xD;
      is increasing, the indications for parenteral nutrition are becoming more strict. The study&#xD;
      aims to identify the role of parenteral nutrition in the context of rapidly changing&#xD;
      supportive care approaches in HSCT&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is interventional: in children and adolescents (2-17 years), adults with blood&#xD;
      malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional&#xD;
      status, parenteral nutrition tolerability and effectiveness will be assessed before and one&#xD;
      month after HSCT. All patients who require parenteral nutrition will pass randomization via&#xD;
      envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid&#xD;
      emulsions. The results will be compared with a control group which will not receive&#xD;
      additional nutritional support. The methods used for measurement of nutritional status are:&#xD;
      weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests,&#xD;
      diet amount record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0</measure>
    <time_frame>60 days</time_frame>
    <description>Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight in HSCT depending on nutritional support approach</measure>
    <time_frame>30 days</time_frame>
    <description>Changes in body weight (kg) from baseline to day +30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index in HSCT depending on nutritional support approach</measure>
    <time_frame>30 days</time_frame>
    <description>Changes in body mass index (kg/m^2) from baseline to day +30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition in HSCT depending on nutritional support approach</measure>
    <time_frame>30 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resting energy expenditure in HSCT depending on nutritional support approach</measure>
    <time_frame>30 days</time_frame>
    <description>Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity and duration of anorexia, nausea, vomiting prevention</measure>
    <time_frame>60 days</time_frame>
    <description>According CTCAE ver. 5.0, amount and duration of patient's oral food intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of parenteral nutrition on infection episodes after HSCT</measure>
    <time_frame>60 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Glucose/Amino acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose/Amino acids/Lipids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucose/Amino acids</intervention_name>
    <description>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.</description>
    <arm_group_label>Glucose/Amino acids</arm_group_label>
    <other_name>Aminoplasmal E 15% 500mL glass bottle</other_name>
    <other_name>Aminoplasmal E 10% 500mL glass bottle</other_name>
    <other_name>Aminoven infant 10% 100mL glass bottle</other_name>
    <other_name>Nutriflex 48/150 1000mL polyethylene 2-chamber bag</other_name>
    <other_name>Nutriflex 70/240 1500mL polyethylene 2-chamber bag</other_name>
    <other_name>Glucose 20% 500mL polyethylene bottle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucose/Amino acids/Lipids</intervention_name>
    <description>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.</description>
    <arm_group_label>Glucose/Amino acids/Lipids</arm_group_label>
    <other_name>Aminoplasmal E 15% 500mL glass bottle</other_name>
    <other_name>SMOFlipid 20% 100mL, 250mL, 500mL glass bottle</other_name>
    <other_name>Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag</other_name>
    <other_name>Aminoplasmal E 10% 500mL glass bottle</other_name>
    <other_name>Aminoven infant 10% 100mL glass bottle</other_name>
    <other_name>Nutriflex 48/150 1000mL polyethylene 2-chamber bag</other_name>
    <other_name>Nutriflex 70/240 1500mL polyethylene 2-chamber bag</other_name>
    <other_name>SMOFKabiven 1477mL polyethylene 3-chamber bag</other_name>
    <other_name>Glucose 20% 500mL polyethylene bottle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Autologous HSCT&#xD;
&#xD;
          -  Allogeneic HSCT&#xD;
&#xD;
          -  Patients with indications for parenteral nutrition defined as unable to eat more than&#xD;
             50% of oral food intake due to posttransplant complications which leads to&#xD;
             malnutrition and malabsorption&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Age &gt; 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Secondary HSCT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Kulagin, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Pavlov First Saint-Petersburg State Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pavlov First Saint-Petersburg State Medical University</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Petersburg State Pavlov Medical University</investigator_affiliation>
    <investigator_full_name>Ivan S Moiseev</investigator_full_name>
    <investigator_title>Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation</investigator_title>
  </responsible_party>
  <keyword>HSCT</keyword>
  <keyword>Parenteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
    <mesh_term>SMOFlipid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04425642
org study id: hsct/pn
nct id: NCT04425642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
time frame: 60 days
description: Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition
measure: Changes in body weight in HSCT depending on nutritional support approach
time frame: 30 days
description: Changes in body weight (kg) from baseline to day +30
measure: Changes in body mass index in HSCT depending on nutritional support approach
time frame: 30 days
description: Changes in body mass index (kg/m^2) from baseline to day +30
measure: Changes in body composition in HSCT depending on nutritional support approach
time frame: 30 days
description: 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
measure: Changes in resting energy expenditure in HSCT depending on nutritional support approach
time frame: 30 days
description: Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan)
measure: Severity and duration of anorexia, nausea, vomiting prevention
time frame: 60 days
description: According CTCAE ver. 5.0, amount and duration of patient's oral food intake
measure: Impact of parenteral nutrition on infection episodes after HSCT
time frame: 60 days
description: 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.
arm group label: Glucose/Amino acids
arm group type: Experimental
description: Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight
arm group label: Glucose/Amino acids/Lipids
arm group type: Experimental
description: Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight
intervention type: Drug
intervention name: Glucose/Amino acids
description: 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.
arm group label: Glucose/Amino acids
other name: Aminoplasmal E 15% 500mL glass bottle
other name: Aminoplasmal E 10% 500mL glass bottle
other name: Aminoven infant 10% 100mL glass bottle
other name: Nutriflex 48/150 1000mL polyethylene 2-chamber bag
other name: Nutriflex 70/240 1500mL polyethylene 2-chamber bag
other name: Glucose 20% 500mL polyethylene bottle
intervention type: Drug
intervention name: Glucose/Amino acids/Lipids
description: 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.
arm group label: Glucose/Amino acids/Lipids
other name: Aminoplasmal E 15% 500mL glass bottle
other name: SMOFlipid 20% 100mL, 250mL, 500mL glass bottle
other name: Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag
other name: Aminoplasmal E 10% 500mL glass bottle
other name: Aminoven infant 10% 100mL glass bottle
other name: Nutriflex 48/150 1000mL polyethylene 2-chamber bag
other name: Nutriflex 70/240 1500mL polyethylene 2-chamber bag
other name: SMOFKabiven 1477mL polyethylene 3-chamber bag
other name: Glucose 20% 500mL polyethylene bottle
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Kulagin, Professor
role: Study Director
affiliation: Pavlov First Saint-Petersburg State Medical University
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: St. Petersburg State Pavlov Medical University
investigator full name: Ivan S Moiseev
investigator title: Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation
mesh term: Hematologic Neoplasms
mesh term: Methamphetamine
mesh term: SMOFlipid
sharing ipd: No