<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/NCT02996240</url>
  </required_header>
  <id_info>
    <org_study_id>CTMS 16-0119</org_study_id>
    <secondary_id>16-665H</secondary_id>
    <nct_id>NCT02996240</nct_id>
  </id_info>
  <brief_title>Breast, Omega 3 Free Fatty Acid, Ph 0</brief_title>
  <official_title>A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the impact of dietary omega 3 free fatty acids breast cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred&#xD;
      (200) newly diagnosed breast cancer patients will be recruited to participate in a short term&#xD;
      (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be&#xD;
      receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">February 22, 2021</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</primary_completion_date>
  <phase>N/A</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>Change in serum colony stimulating factor at surgery</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in circulating levels of pro-inflammatory cytokines.</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in circulating levels of eicosanoids.</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in circulating levels of metabolics.</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>Omega-3 FFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 FFA</intervention_name>
    <description>Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.</description>
    <arm_group_label>Omega-3 FFA</arm_group_label>
    <other_name>Omacor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  ECOG ≤2&#xD;
&#xD;
          -  Ability to understand the purposes and risks of the study and has signed a written&#xD;
             informed consent form approved by the investigator's IRB/Ethics Committee&#xD;
&#xD;
          -  Consented for tissue collection on CTRC repository 07-32&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active systemic illness (infection including viral illnesses such as Hepatitis and&#xD;
             HIV)&#xD;
&#xD;
          -  Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60&#xD;
             days (defined as greater than or equal to 7 consecutive days)&#xD;
&#xD;
          -  Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days&#xD;
&#xD;
          -  History of medical noncompliance&#xD;
&#xD;
          -  Scheduled date of surgical resection that would limit the amount of time taking the&#xD;
             intervention to less than 21 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia G Kaklamani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CTRC at University of Texas Health Science Center San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Virginia G. Kaklamani</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>Breast 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/NCT02996240
org study id: CTMS 16-0119
secondary id: 16-665H
nct id: NCT02996240
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Assess the impact of dietary omega 3 free fatty acids breast cancer patients.
Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred
      (200) newly diagnosed breast cancer patients will be recruited to participate in a short term
      (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be
      receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in serum colony stimulating factor at surgery
time frame: 30 days
measure: Change in circulating levels of pro-inflammatory cytokines.
time frame: 30 days
measure: Change in circulating levels of eicosanoids.
time frame: 30 days
measure: Change in circulating levels of metabolics.
time frame: 30 days
arm group label: Omega-3 FFA
arm group type: Experimental
description: Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).
intervention type: Dietary Supplement
intervention name: Omega-3 FFA
description: Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
arm group label: Omega-3 FFA
other name: Omacor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Virginia G Kaklamani, MD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Virginia G. Kaklamani
investigator title: Principal Investigator
mesh term: Breast Neoplasms