xml: <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/NCT06004063</url>
    </required_header>
    <id_info>
      <org_study_id>2021-0116</org_study_id>
      <secondary_id>NCI-2023-06448</secondary_id>
      <nct_id>NCT06004063</nct_id>
    </id_info>
    <brief_title>Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study</brief_title>
    <official_title>Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>M.D. Anderson Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this research study is to learn if feeding someone after a stem cell transplant&#xD;
        is safe and practical.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
        a. To determine feasibility of administering enteral nutrition (EN) via NG/GT in SCT&#xD;
        population in peri-transplant period.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          1. Determine the differential effects of enteral feeding versus Parenteral feeding on&#xD;
             nutrition, and quality of life.&#xD;
  &#xD;
          2. Determine the differential effects of enteral feeding versus parenteral feeding on&#xD;
             survival and, medical comorbidities&#xD;
  &#xD;
          3. Determine the differential effects of enteral feeding versus parenteral feeding on&#xD;
             Fitbit data study for patients co-enrolled in Pediatric Energy Balance Data Repository&#xD;
             Protocol PA18-0130.&#xD;
  &#xD;
          4. Identify differential effects on microbiome for patients co-enrolled on &quot;A Study to&#xD;
             Collect Peripheral Blood, Tissue, and Bone Marrow samples from Donors and Recipients of&#xD;
             blood and marrow transplants for Laboratory Research Protocol Lab99-062&quot;.&#xD;
  &#xD;
          5. Determine adverse effects of enteral feeding in this population&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0</measure>
      <time_frame>through study completion; an average of 1 year.</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Stem Cell</condition>
    <arm_group>
      <arm_group_label>Enteral nutrition (EN)-Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care parenteral nutrition (PN)-Group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive the standard of care. Participants will be monitored by a dietician to see if the participants are able to receive your daily caloric needs by mouth. Some participants may be able to receive oral dietary supplements, but if this is not possible or not enough, participants will begin receiving standard of care feeding by vein.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Enteral nutrition (EN)</intervention_name>
      <description>Given by Nasogastric Tube</description>
      <arm_group_label>Enteral nutrition (EN)-Group 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard care parenteral nutrition (PN)</intervention_name>
      <description>Given by PO or Given by IV (vein)</description>
      <arm_group_label>Enteral nutrition (EN)-Group 1</arm_group_label>
      <arm_group_label>Standard care parenteral nutrition (PN)-Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.&#xD;
  &#xD;
            2. Be greater than 2 years of age and less than 25 years of age at time of study&#xD;
               enrollment.&#xD;
  &#xD;
            3. Participants &gt; 18 or guardians for participants &lt; 18 are willing and able to give&#xD;
               written informed consent and to comply with all of the study activities. Assent is&#xD;
               required for children &gt; 7 years old.&#xD;
  &#xD;
            4. Participants will be encouraged to co-enroll on two additional related energy -balance&#xD;
               protocols (highly encouraged but not required)&#xD;
  &#xD;
            5. Participants will be asked to consider co-enrollment on Stem Cell Registry studies&#xD;
               (not required):&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowel&#xD;
               obstruction, or other anatomical obstructive process), or all available routes of EN&#xD;
               are contraindicated. Surgical GT placements for the sole purpose of study&#xD;
               participation will not be entertained.&#xD;
  &#xD;
            2. Females who are pregnant. We follow FACT guidelines. Per Foundation for the&#xD;
               Accreditation of Cellular Therapy (FACT), female patients must have a negative&#xD;
               pregnancy test 7 days prior to bone marrow transplant. .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shehla Razvi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shehla Razvi, MD</last_name>
      <phone>(713) 792-6635</phone>
      <email>srazvi@mdanderson.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karen Moody, MD</last_name>
      <phone>713-792-6610</phone>
      <email>kmoody@mdanderson.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shehla Razvi, MD</last_name>
        <phone>713-792-6635</phone>
        <email>srazvi@mdanderson.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004063
  org study id: 2021-0116
  secondary id: NCI-2023-06448
  nct id: NCT06004063
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this research study is to learn if feeding someone after a stem cell transplant
        is safe and practical.
  Primary Objective:
  
        a. To determine feasibility of administering enteral nutrition (EN) via NG/GT in SCT
        population in peri-transplant period.
  
        Secondary Objectives:
  
          1. Determine the differential effects of enteral feeding versus Parenteral feeding on
             nutrition, and quality of life.
  
          2. Determine the differential effects of enteral feeding versus parenteral feeding on
             survival and, medical comorbidities
  
          3. Determine the differential effects of enteral feeding versus parenteral feeding on
             Fitbit data study for patients co-enrolled in Pediatric Energy Balance Data Repository
             Protocol PA18-0130.
  
          4. Identify differential effects on microbiome for patients co-enrolled on "A Study to
             Collect Peripheral Blood, Tissue, and Bone Marrow samples from Donors and Recipients of
             blood and marrow transplants for Laboratory Research Protocol Lab99-062".
  
          5. Determine adverse effects of enteral feeding in this population
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
  time frame: through study completion; an average of 1 year.
  arm group label: Enteral nutrition (EN)-Group 1
  arm group type: Experimental
  description: Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals.
  arm group label: Standard care parenteral nutrition (PN)-Group 2
  arm group type: Active Comparator
  description: Participants will receive the standard of care. Participants will be monitored by a dietician to see if the participants are able to receive your daily caloric needs by mouth. Some participants may be able to receive oral dietary supplements, but if this is not possible or not enough, participants will begin receiving standard of care feeding by vein.
  intervention type: Dietary Supplement
  intervention name: Enteral nutrition (EN)
  description: Given by Nasogastric Tube
  arm group label: Enteral nutrition (EN)-Group 1
  intervention type: Other
  intervention name: Standard care parenteral nutrition (PN)
  description: Given by PO or Given by IV (vein)
  arm group label: Enteral nutrition (EN)-Group 1
  arm group label: Standard care parenteral nutrition (PN)-Group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shehla Razvi, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Shehla Razvi, MD
  phone: (713) 792-6635
  email: srazvi@mdanderson.org
  last name: Karen Moody, MD
  phone: 713-792-6610
  email: kmoody@mdanderson.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  sharing ipd: No