<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/NCT01687231</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00012374</org_study_id>
    <secondary_id>Pro00012374</secondary_id>
    <nct_id>NCT01687231</nct_id>
  </id_info>
  <brief_title>Infection Rates of Myeloablative Allo SCT Recipients Receiving Neutropenic Diets Versus Non-Neutropenic Diets</brief_title>
  <official_title>A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the transplant community, there is debate regarding the most appropriate food services for&#xD;
      stem cell transplant patients. Recommendations regarding the use of low bacterial diets have&#xD;
      been based on theoretical concepts of reducing the risk of contracting infections from&#xD;
      pathogens found in food sources rather than clinical trials. The evidence for the use of a&#xD;
      neutropenic diet is weak. To date, there have been little to no randomized controlled studies&#xD;
      addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is&#xD;
      necessary as infection prevention in myeloablative stem cell transplant patients. For this&#xD;
      reason, our research is aimed at providing data to substantiate the use of neutropenic diets&#xD;
      in preventing infections in recipients of myeloablative stem cell transplants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the proposed pilot study, a randomized design will be used to address the primary and&#xD;
      secondary aims. Subjects will be randomized to either the experimental group receiving a&#xD;
      non-neutropenic diet without restriction, or to the control group receiving the standard&#xD;
      neutropenic diet. While randomization will occur prior to, or on the day of their inpatient&#xD;
      admission and the subjects will begin study procedures upon admission to the Adult Stem Cell&#xD;
      Transplant Inpatient Unit at Duke University Medical Center.&#xD;
&#xD;
      The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged&#xD;
      from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient&#xD;
      Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the&#xD;
      opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as&#xD;
      an absolute neutrophil count of greater than 500/uL (manual differential) and a total white&#xD;
      blood cell count of 1000/uL for three consecutive days.&#xD;
&#xD;
      All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other&#xD;
      supportive care will also be consistent in the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Bacteremia</measure>
    <time_frame>Duration of hospitalization or neutropenia, an expected average of 5 weeks.</time_frame>
    <description>Participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will be measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess nutritional status using PG-SGA</measure>
    <time_frame>Duration of hospitalization or neutropenia, an expected average of 5 weeks.</time_frame>
    <description>The participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks. The nutritional status will be assessed by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) platform.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Hematologic Malignancies</condition>
  <arm_group>
    <arm_group_label>Neutropenic Diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm is the control and subjects will receive the standard of care neutropenic diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-neutropenic Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm is interventional and subjects will receive a non-neutropenic diet without restriction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-neutropenic Diet</intervention_name>
    <description>Non-neutropenic diet is without restriction.</description>
    <arm_group_label>Non-neutropenic Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Scheduled to undergo a myeloablative allogeneic stem cell transplant for any cancer or&#xD;
             non-cancer illness from any related or unrelated donor source including bone marrow,&#xD;
             peripheral blood progenitor cell, or umbilical cord blood&#xD;
&#xD;
          2. Age 20-70 years of age&#xD;
&#xD;
          3. Karnofsky Performance Scale KPS&gt; 80&#xD;
&#xD;
          4. Ability to read and write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Autologous stem cell transplant recipients&#xD;
&#xD;
          2. Non-myeloablative or reduced intensity stem cell transplant recipients&#xD;
&#xD;
          3. Pregnant women&#xD;
&#xD;
          4. Patients with a documented active infection prior to starting their preparative&#xD;
             regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelson Chao, MD, MBA</last_name>
    <role>Study Chair</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>May 8, 2013</last_update_submitted>
  <last_update_submitted_qc>May 8, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neutropenic Diet, Non-Neutropenic Diet, Allogeneic SCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</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/NCT01687231
org study id: Pro00012374
secondary id: Pro00012374
nct id: NCT01687231
lead sponsor: 
has dmc: Yes
In the transplant community, there is debate regarding the most appropriate food services for
      stem cell transplant patients. Recommendations regarding the use of low bacterial diets have
      been based on theoretical concepts of reducing the risk of contracting infections from
      pathogens found in food sources rather than clinical trials. The evidence for the use of a
      neutropenic diet is weak. To date, there have been little to no randomized controlled studies
      addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is
      necessary as infection prevention in myeloablative stem cell transplant patients. For this
      reason, our research is aimed at providing data to substantiate the use of neutropenic diets
      in preventing infections in recipients of myeloablative stem cell transplants.
In the proposed pilot study, a randomized design will be used to address the primary and
      secondary aims. Subjects will be randomized to either the experimental group receiving a
      non-neutropenic diet without restriction, or to the control group receiving the standard
      neutropenic diet. While randomization will occur prior to, or on the day of their inpatient
      admission and the subjects will begin study procedures upon admission to the Adult Stem Cell
      Transplant Inpatient Unit at Duke University Medical Center.

      The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged
      from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient
      Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the
      opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as
      an absolute neutrophil count of greater than 500/uL (manual differential) and a total white
      blood cell count of 1000/uL for three consecutive days.

      All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other
      supportive care will also be consistent in the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Bacteremia
time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.
description: Participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will be measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks.
measure: Assess nutritional status using PG-SGA
time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.
description: The participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks. The nutritional status will be assessed by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) platform.
arm group label: Neutropenic Diet
arm group type: No Intervention
description: This arm is the control and subjects will receive the standard of care neutropenic diet.
arm group label: Non-neutropenic Diet
arm group type: Experimental
description: This arm is interventional and subjects will receive a non-neutropenic diet without restriction.
intervention type: Other
intervention name: Non-neutropenic Diet
description: Non-neutropenic diet is without restriction.
arm group label: Non-neutropenic Diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nelson Chao, MD, MBA
role: Study Chair
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematologic Neoplasms