xml: <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/NCT06017661</url>
    </required_header>
    <id_info>
      <org_study_id>09-AP-ONCON</org_study_id>
      <nct_id>NCT06017661</nct_id>
    </id_info>
    <brief_title>Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection</brief_title>
    <official_title>Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</source>
    <oversight_info>
      <has_dmc>No</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>
        The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the&#xD;
        standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic&#xD;
        compounds in the aspect of supporting the recovery of oncology patients undergoing surgical&#xD;
        resection of tumours.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Oncology patients undergoing the procedure are exposed to various postoperative&#xD;
        complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative&#xD;
        properties aims to provide the patient with essential nutrients and bioactive substances that&#xD;
        can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk&#xD;
        of complications while supporting tissue healing processes after the surgical procedure. The&#xD;
        study group are oncology patients undergoing surgical resection of gastrointestinal tumour.&#xD;
        During the study, the effects of the mixture on levels of oxidative stress and inflammation&#xD;
        markers will be assessed, as well as the subjective evaluation of patients' quality of life&#xD;
        and well-being after surgical surgical tumor resection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>SOD level</measure>
      <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
      <description>Comparison of SOD level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GSH level</measure>
      <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
      <description>Comparison of GSH level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IL-6 level</measure>
      <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
      <description>Comparison of IL-6 level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IL-8 level</measure>
      <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
      <description>Comparison of IL-8 level</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients' quality of life</measure>
      <time_frame>Baseline, 3 weeks, 6 weeks</time_frame>
      <description>Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Immunomodulation</condition>
    <arm_group>
      <arm_group_label>Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of 15 patients undergoing surgical resection of tumour</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutridrink Skin Repair</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group of 15 patients undergoing surgical resection of tumour</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds</intervention_name>
      <description>2 times a day</description>
      <arm_group_label>Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Nutridrink Skin Repair</intervention_name>
      <description>2 times a day</description>
      <arm_group_label>Nutridrink Skin Repair</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 18-80 years old&#xD;
  &#xD;
            -  Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection&#xD;
               procedure no later than one month after being enrolled in the study&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins&#xD;
  &#xD;
            -  Participation in another clinical trial&#xD;
  &#xD;
            -  Inability to consume the investigational product in liquid form as medication/placebo&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study or breastfeeding&#xD;
  &#xD;
            -  Autoimmune disease, severe liver dysfunction, inflammatory bowel disease,&#xD;
               tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation&#xD;
  &#xD;
            -  Hypersensitivity/allergy to any of the ingredient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne</name>
        <address>
          <city>Gdańsk</city>
          <zip>80-214</zip>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Barbara Khaidakov, PhD</last_name>
        <phone>798 210 651</phone>
        <phone_ext>+48</phone_ext>
        <email>barbara.khaidakov@aronpharma.pl</email>
      </contact>
      <investigator>
        <last_name>Piotr Spychalski</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chokeberry</keyword>
    <keyword>Nutridrink</keyword>
    <keyword>immunomodulation</keyword>
    <keyword>tumor resection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Digestive System Neoplasms</mesh_term>
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017661
  org study id: 09-AP-ONCON
  nct id: NCT06017661
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the
        standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic
        compounds in the aspect of supporting the recovery of oncology patients undergoing surgical
        resection of tumours.
  Oncology patients undergoing the procedure are exposed to various postoperative
        complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative
        properties aims to provide the patient with essential nutrients and bioactive substances that
        can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk
        of complications while supporting tissue healing processes after the surgical procedure. The
        study group are oncology patients undergoing surgical resection of gastrointestinal tumour.
        During the study, the effects of the mixture on levels of oxidative stress and inflammation
        markers will be assessed, as well as the subjective evaluation of patients' quality of life
        and well-being after surgical surgical tumor resection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: SOD level
  time frame: Baseline, 3 weeks, 6 weeks
  description: Comparison of SOD level
  measure: GSH level
  time frame: Baseline, 3 weeks, 6 weeks
  description: Comparison of GSH level
  measure: IL-6 level
  time frame: Baseline, 3 weeks, 6 weeks
  description: Comparison of IL-6 level
  measure: IL-8 level
  time frame: Baseline, 3 weeks, 6 weeks
  description: Comparison of IL-8 level
  measure: Patients' quality of life
  time frame: Baseline, 3 weeks, 6 weeks
  description: Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire).
  arm group label: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
  arm group type: Experimental
  description: Group of 15 patients undergoing surgical resection of tumour
  arm group label: Nutridrink Skin Repair
  arm group type: Active Comparator
  description: Group of 15 patients undergoing surgical resection of tumour
  intervention type: Dietary Supplement
  intervention name: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
  description: 2 times a day
  arm group label: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
  intervention type: Dietary Supplement
  intervention name: Nutridrink Skin Repair
  description: 2 times a day
  arm group label: Nutridrink Skin Repair
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  contact: 
  investigator: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Digestive System Neoplasms
  mesh term: Gastrointestinal Neoplasms
  sharing ipd: No