<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/NCT03819088</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00099791</org_study_id>
    <secondary_id>NCI-2017-02467</secondary_id>
    <secondary_id>Winship4173-17</secondary_id>
    <secondary_id>P30CA138292</secondary_id>
    <nct_id>NCT03819088</nct_id>
  </id_info>
  <brief_title>Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer</brief_title>
  <official_title>Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</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>
      This randomized study examines how well zinc works in improving quality of life in patients&#xD;
      with gastrointestinal cancer that cannot be removed by surgery who are receiving&#xD;
      chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc&#xD;
      deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Assess the effects on quality of life (QOL) when supplementing zinc in upper&#xD;
      gastrointestinal (GI) cancer patients while they are receiving chemotherapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Correlate hypoalbuminemia with serum zinc deficiency.&#xD;
&#xD;
      II. Correlate zinc deficiency with neutropenia.&#xD;
&#xD;
      OUTLINE: Patients are randomized into 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the&#xD;
      first 4 months on therapy.&#xD;
&#xD;
      GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months&#xD;
      on therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Anticipated">August 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 22, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life scores</measure>
    <time_frame>Up to 4 months after study start</time_frame>
    <description>Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum zinc level</measure>
    <time_frame>Up to 4 months after study start</time_frame>
    <description>Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum albumin level</measure>
    <time_frame>Up to 4 months after study start</time_frame>
    <description>Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Gastric Carcinoma</condition>
  <condition>Liver and Intrahepatic Bile Duct Carcinoma</condition>
  <condition>Unresectable Esophageal Carcinoma</condition>
  <condition>Unresectable Pancreatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group I (zinc months 1 and 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (zinc months 3 and 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Zinc</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (zinc months 1 and 2)</arm_group_label>
    <arm_group_label>Group II (zinc months 3 and 4)</arm_group_label>
    <other_name>Zinc sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present to adult medical oncology outpatient clinic with new diagnosis of&#xD;
             non-resectable gastric, gastro-esophageal, pancreas or biliary cancer&#xD;
&#xD;
          -  Patients plan to receive chemotherapy at an Emory Cancer Center&#xD;
&#xD;
          -  No prior chemotherapy or radiation therapy for newly diagnosed gastric,&#xD;
             gastro-esophageal, pancreas or biliary cancer&#xD;
&#xD;
          -  Patients must sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Zinc supplementation is not indicated for pregnant or lactating women therefore, this&#xD;
             is an exclusion criteria and women of childbearing age will complete a pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Jones, NP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 12, 2023</last_update_submitted>
  <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Aaron T. Jones</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc</mesh_term>
    <mesh_term>Zinc Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Plan may be reevaluated at the time of publication.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03819088/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03819088
org study id: IRB00099791
secondary id: NCI-2017-02467
secondary id: Winship4173-17
secondary id: P30CA138292
nct id: NCT03819088
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized study examines how well zinc works in improving quality of life in patients
      with gastrointestinal cancer that cannot be removed by surgery who are receiving
      chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc
      deficiency.
PRIMARY OBJECTIVE:

      I. Assess the effects on quality of life (QOL) when supplementing zinc in upper
      gastrointestinal (GI) cancer patients while they are receiving chemotherapy.

      SECONDARY OBJECTIVES:

      I. Correlate hypoalbuminemia with serum zinc deficiency.

      II. Correlate zinc deficiency with neutropenia.

      OUTLINE: Patients are randomized into 1 of 2 groups.

      GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the
      first 4 months on therapy.

      GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months
      on therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quality of life scores
time frame: Up to 4 months after study start
description: Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.
measure: Serum zinc level
time frame: Up to 4 months after study start
description: Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.
measure: Serum albumin level
time frame: Up to 4 months after study start
description: Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.
arm group label: Group I (zinc months 1 and 2)
arm group type: Experimental
description: Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
arm group label: Group II (zinc months 3 and 4)
arm group type: Experimental
description: Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
intervention type: Dietary Supplement
intervention name: Zinc
description: Given PO
arm group label: Group I (zinc months 1 and 2)
arm group label: Group II (zinc months 3 and 4)
other name: Zinc sulfate
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Aaron Jones, NP
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Aaron T. Jones
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Pancreatic Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Stomach Neoplasms
mesh term: Zinc
mesh term: Zinc Sulfate
sharing ipd: No
ipd description: Plan may be reevaluated at the time of publication.
provided document: 