<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/NCT02261844</url>
  </required_header>
  <id_info>
    <org_study_id>ResveraCA</org_study_id>
    <nct_id>NCT02261844</nct_id>
  </id_info>
  <brief_title>Resveratrol and Human Hepatocyte Function in Cancer</brief_title>
  <official_title>Resveratrol and Human Hepatocyte Function in Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a&#xD;
      beneficial effect in the cellular function of normal liver cells and diseased liver cells&#xD;
      (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based&#xD;
      on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement&#xD;
      will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation&#xD;
      of cancer cells, 3)decrease inflammation in the liver.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling&#xD;
      pathway proteins will be measured using western blot analysis for protein expression and&#xD;
      polymerase chain reaction for gene expression. Activation of signaling pathways in both&#xD;
      native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on&#xD;
      transcription factors that may be important in gene expression will be analyzed by&#xD;
      transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell&#xD;
      metabolism will be analyzed by proteomic analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funding&#xD;
  </why_stopped>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved metabolic profile of liver cells</measure>
    <time_frame>36 months</time_frame>
    <description>This outcome is a composite outcome and will be measured by assessing expression of multiple signaling proteins that are important in hepatic cell metabolism such as Akt, p38, Mitogen Activated Kinases, and Adenosine Monophosphate-activated Kinase (AMPK) and expression of gluconeogenic proteins such as Phosphoenolpyruvate carboxykinase (PEPCK).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decreased cell growth and proliferation</measure>
    <time_frame>36 months</time_frame>
    <description>This outcome is a composite outcome of cellular pathways important in cancer cell replication. This will be measured by the expression of genes and proteins that regulate hepatic cell growth/cell survival such as cyclin gene expression, expression of the tumor suppressor p53, and expression of apoptosis proteins Bcl-2 and Bcl-xl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased hepatic inflammation</measure>
    <time_frame>36 months</time_frame>
    <description>This outcome will be a composite outcome of pathways that regulate both cancer cell growth and inflammation. It will be measured by levels of genes and proteins for nitric oxide synthase, cytokines such as interleukin-6, and Nuclear Factor-kappa B signaling proteins.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>resveratrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resveratrol 1 g daily for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 1 pill daily for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>Resveratrol 1 gm po x 10 days prior to liver resection</description>
    <arm_group_label>resveratrol</arm_group_label>
    <other_name>Biotivia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 1 pill daily X 10 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing elective liver resection for liver cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak or read English&#xD;
&#xD;
          -  Sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure&#xD;
&#xD;
          -  History of daily alcohol intake&#xD;
&#xD;
          -  Presence of human immunodeficiency virus&#xD;
&#xD;
          -  Presence of significant renal dysfunction as defined by baseline serum creatinine &gt;&#xD;
             2.0 mg/dl or need/impending need for chronic dialysis therapy&#xD;
&#xD;
          -  Known allergy to the study medication&#xD;
&#xD;
          -  Pregnancy, lactating women, women contemplating pregnancy during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian G Harbrecht, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>May 20, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Brian G. Harbrecht</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Metastatic colorectal cancer</keyword>
  <keyword>Metabolism</keyword>
  <keyword>Hepatic function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
  </intervention_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/NCT02261844
org study id: ResveraCA
nct id: NCT02261844
lead sponsor: 
has dmc: No
The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a
      beneficial effect in the cellular function of normal liver cells and diseased liver cells
      (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based
      on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement
      will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation
      of cancer cells, 3)decrease inflammation in the liver.
Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling
      pathway proteins will be measured using western blot analysis for protein expression and
      polymerase chain reaction for gene expression. Activation of signaling pathways in both
      native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on
      transcription factors that may be important in gene expression will be analyzed by
      transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell
      metabolism will be analyzed by proteomic analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Improved metabolic profile of liver cells
time frame: 36 months
description: This outcome is a composite outcome and will be measured by assessing expression of multiple signaling proteins that are important in hepatic cell metabolism such as Akt, p38, Mitogen Activated Kinases, and Adenosine Monophosphate-activated Kinase (AMPK) and expression of gluconeogenic proteins such as Phosphoenolpyruvate carboxykinase (PEPCK).
measure: Decreased cell growth and proliferation
time frame: 36 months
description: This outcome is a composite outcome of cellular pathways important in cancer cell replication. This will be measured by the expression of genes and proteins that regulate hepatic cell growth/cell survival such as cyclin gene expression, expression of the tumor suppressor p53, and expression of apoptosis proteins Bcl-2 and Bcl-xl.
measure: Decreased hepatic inflammation
time frame: 36 months
description: This outcome will be a composite outcome of pathways that regulate both cancer cell growth and inflammation. It will be measured by levels of genes and proteins for nitric oxide synthase, cytokines such as interleukin-6, and Nuclear Factor-kappa B signaling proteins.
arm group label: resveratrol
arm group type: Experimental
description: Resveratrol 1 g daily for 10 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 1 pill daily for 10 days
intervention type: Dietary Supplement
intervention name: Resveratrol
description: Resveratrol 1 gm po x 10 days prior to liver resection
arm group label: resveratrol
other name: Biotivia
intervention type: Drug
intervention name: Placebo
description: Placebo 1 pill daily X 10 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Brian G Harbrecht, MD
role: Principal Investigator
affiliation: University of Louisville
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Brian G. Harbrecht
investigator title: MD
mesh term: Liver Neoplasms
mesh term: Resveratrol