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/NCT06015971</url>
    </required_header>
    <id_info>
      <org_study_id>Sarcopenia omega3</org_study_id>
      <nct_id>NCT06015971</nct_id>
    </id_info>
    <brief_title>Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer</brief_title>
    <official_title>Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maimónides Biomedical Research Institute of Córdoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maimónides Biomedical Research Institute of Córdoba</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>
        Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is&#xD;
        characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass,&#xD;
        which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it&#xD;
        negatively impacts treatment tolerance, clinical outcomes and survival, in consequence,&#xD;
        quality of life of these patients decreases while morbidity, mortality and costs increase. In&#xD;
        this context, appropriate nutritional screening and early nutrition support are extremely&#xD;
        recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary;&#xD;
        ONS could have a standard formula or be enriched with specific nutrients (arginine,&#xD;
        glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate&#xD;
        the activity of the immune system and provide an additional benefit beyond the nutritional&#xD;
        support, this intervention type is called immunonutrition. Despite these possible benefits,&#xD;
        their utility has been proven in few clinical scenarios, for example in with patients with&#xD;
        upper gastrointestinal cancer undergoing surgical resection; based on this, current&#xD;
        guidelines recommend that patients should receive oral/enteral nutritional support with an&#xD;
        specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides)&#xD;
        , but there is a lack of evidence for supporting its use in other clinical conditions&#xD;
        including patients with cancer that receive systemic treatment&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>Muscle mass</measure>
      <time_frame>12 weeks</time_frame>
      <description>Muscle mass change (in Kg)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functionality</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in functionality measured with the Up and Go Test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Albumin</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in serum albumin levels (g/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-RP</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in serum C-RP(g/dl)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Sarcopenia</condition>
    <arm_group>
      <arm_group_label>standard hypercaloric, hyperproteic oral supplement</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>omega-3 enriched oral supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>omega-3</intervention_name>
      <description>Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet</description>
      <arm_group_label>omega-3 enriched oral supplement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Standard</intervention_name>
      <description>Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet</description>
      <arm_group_label>standard hypercaloric, hyperproteic oral supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Patients with Gastrointestinal tumor undergoing systemic treatment&#xD;
               (chemo-radio-immuno therapy or their combination)&#xD;
  &#xD;
            -  Body weight loss &gt;5% in the previous three months or &gt;10% in the previous six months&#xD;
  &#xD;
            -  Both sexes&#xD;
  &#xD;
            -  Age between 18-85 y-old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Life expectancy &lt; 2 weeks&#xD;
  &#xD;
            -  MDRD &lt; 15 mL/min&#xD;
  &#xD;
            -  End-stage liver disease&#xD;
  &#xD;
            -  Any musculoskeletal, cardiovascular and/or neurological disorders that could affect&#xD;
               exercising.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>IMIBIC</name>
        <address>
          <city>Cordoba</city>
          <zip>14004</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jose Carlos Garrido, PhD</last_name>
        <phone>957 213831</phone>
        <email>josecarlos.garrido@imibic.org</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cancer</keyword>
    <keyword>nutritional support</keyword>
    <keyword>omega-3 enriched nutritional supplements</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06015971
  org study id: Sarcopenia omega3
  nct id: NCT06015971
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is
        characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass,
        which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it
        negatively impacts treatment tolerance, clinical outcomes and survival, in consequence,
        quality of life of these patients decreases while morbidity, mortality and costs increase. In
        this context, appropriate nutritional screening and early nutrition support are extremely
        recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary;
        ONS could have a standard formula or be enriched with specific nutrients (arginine,
        glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate
        the activity of the immune system and provide an additional benefit beyond the nutritional
        support, this intervention type is called immunonutrition. Despite these possible benefits,
        their utility has been proven in few clinical scenarios, for example in with patients with
        upper gastrointestinal cancer undergoing surgical resection; based on this, current
        guidelines recommend that patients should receive oral/enteral nutritional support with an
        specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides)
        , but there is a lack of evidence for supporting its use in other clinical conditions
        including patients with cancer that receive systemic treatment
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Muscle mass
  time frame: 12 weeks
  description: Muscle mass change (in Kg)
  measure: Functionality
  time frame: 12 weeks
  description: Changes in functionality measured with the Up and Go Test
  measure: Albumin
  time frame: 12 weeks
  description: Changes in serum albumin levels (g/dl)
  measure: C-RP
  time frame: 12 weeks
  description: Changes in serum C-RP(g/dl)
  arm group label: standard hypercaloric, hyperproteic oral supplement
  arm group type: Active Comparator
  arm group label: omega-3 enriched oral supplement
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: omega-3
  description: Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
  arm group label: omega-3 enriched oral supplement
  intervention type: Dietary Supplement
  intervention name: Standard
  description: Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
  arm group label: standard hypercaloric, hyperproteic oral supplement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Gastrointestinal Neoplasms
  mesh term: Sarcopenia
  sharing ipd: Undecided