<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/NCT01699581</url>
  </required_header>
  <id_info>
    <org_study_id>11-HEM-03-MCC</org_study_id>
    <nct_id>NCT01699581</nct_id>
  </id_info>
  <brief_title>Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant</brief_title>
  <official_title>Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Greg Monohan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nestle Impact has shown efficacy in multiple surgical trials in relation to improving&#xD;
      hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be&#xD;
      taken orally three times a day beginning on the morning following stem cell transplant and&#xD;
      will continue until the day of hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Research cancelled following interim analysis&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Days to engraftment</measure>
    <time_frame>Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Hodgkin's Lymphoma</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>Nestle Impact Advanced Recovery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nestle Impact Advanced Recovery&#xD;
1 dose of Nestle Impact Advanced Recovery orally three times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nestle Impact Advanced Recovery</intervention_name>
    <description>dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.</description>
    <arm_group_label>Nestle Impact Advanced Recovery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving an autologous stem cell transplant using the preparative regimens&#xD;
             of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or&#xD;
             Melphalan 200mg/m2&#xD;
&#xD;
          -  Any prior diet or supplement will be allowed.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to Nestle Impact including fish oil.&#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>Greg Monohan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lucille P. Markey Cancer Center at University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky, Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Greg Monohan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hodgkin's Lymphoma</keyword>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Non-Hodgkin's Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01699581
org study id: 11-HEM-03-MCC
nct id: NCT01699581
lead sponsor: 
has dmc: Yes
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving
      hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be
      taken orally three times a day beginning on the morning following stem cell transplant and
      will continue until the day of hospital discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital length of stay
time frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
measure: Days to engraftment
time frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
arm group label: Nestle Impact Advanced Recovery
arm group type: Experimental
description: Nestle Impact Advanced Recovery
1 dose of Nestle Impact Advanced Recovery orally three times a day
intervention type: Dietary Supplement
intervention name: Nestle Impact Advanced Recovery
description: dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.
arm group label: Nestle Impact Advanced Recovery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Greg Monohan, MD
role: Principal Investigator
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Greg Monohan
investigator title: Principal Investigator
mesh term: Lymphoma
mesh term: Multiple Myeloma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease