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/NCT05968677</url>
    </required_header>
    <id_info>
      <org_study_id>SELECT-BC</org_study_id>
      <nct_id>NCT05968677</nct_id>
    </id_info>
    <brief_title>Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients</brief_title>
    <official_title>Pragmatic, Controlled, Single-Center, Randomized Clinical Trial to Evaluate the Effect of Supplementation With an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Flavolife Srl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Flavolife Srl</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effect of a Food for Special Medical&#xD;
        Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional&#xD;
        counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status&#xD;
        and quality of life in patients with breast cancer.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  can this dietary supplementation affect the nutritional status of breast cancer&#xD;
             patients?&#xD;
  &#xD;
          -  can this dietary supplementation have any beneficial effect on chemotoxicity?&#xD;
             Participants will be asked to undergo nutritional counseling and to take the study&#xD;
             product every day for 12 weeks.&#xD;
  &#xD;
        Researchers will compare a similar group of participants only receiving the nutritional&#xD;
        counseling to see if any difference occurs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be selected at the first oncological visit at the Outpatient Clinics or the&#xD;
        Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor,&#xD;
        evaluated the inclusion and exclusion criteria, will propose patient to participate in the&#xD;
        study and, after obtaining informed consent, will proceed with enrollment. On the first day&#xD;
        of chemotherapy, participants will undergo an oncological and nutritional examination, with&#xD;
        collection of anthropometric data, assessment of body composition, assessment of quality of&#xD;
        life through special validated questionnaires, blood sampling for blood chemistry tests and&#xD;
        urine collection. Participants in the treated group will receive a supply of the FSMP to take&#xD;
        home. At check-up visits, the participant's nutritional status and any adverse events will be&#xD;
        assessed, other than adherence to treatment by delivery of empty product boxes and&#xD;
        chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first&#xD;
        chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity</measure>
      <time_frame>0, 6, 12 weeks</time_frame>
      <description>The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)</measure>
      <time_frame>0, 3, 6, 9, 12 weeks</time_frame>
      <description>Participant's weight in kilograms and height in meters will be combined to report BMI and FFMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline in Phase Angle</measure>
      <time_frame>0, 3, 6, 9, 12 weeks</time_frame>
      <description>Participant's body composition will be evaluated through measurement of the phase angle which represents the relationship between resistance and capacitive reactance of the body and bioimpedance diagnostics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)</measure>
      <time_frame>0, 3, 6, 9, 12 weeks</time_frame>
      <description>Participant's water and nutritional status will be evaluated</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>3, 6, 9, 12 weeks</time_frame>
      <description>Proportion of participants with adverse events of any type and specifically haematological, cardiac, gastrointestinal, hepatobiliary, metabolic, psychiatric, renal and urinary types, distinguishing between grade 1-2, grade 3-4 and grade 5.&#xD;
  Furthermore, the proportion of participants who discontinue chemotherapy treatment and the change in the number of participants who reduce their chemotherapy dose during the treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline in Interleukine-6 levels</measure>
      <time_frame>0, 6, 12 weeks</time_frame>
      <description>The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline Interleukine-1 beta levels</measure>
      <time_frame>0, 6, 12 weeks</time_frame>
      <description>The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change from baseline in C-reactive Protein levels</measure>
      <time_frame>0, 6, 12 weeks</time_frame>
      <description>The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's perception of her physical and mental state</measure>
      <time_frame>0, 12 weeks</time_frame>
      <description>Comparison of the total average values resulting from the compilation of two validated oncological questionnaires, which include questions with scores from 1 to 4, where in general higher scores mean a worse outcome</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>FSMP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nutritional counseling plus one sachet of the study product (6.5 g) per day, away from meals, starting the day after the first chemotherapy cycle until three weeks after the last chemotherapy cycle (for a total of 12 weeks)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Nutritional counseling</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>FSMP</intervention_name>
      <description>Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy</description>
      <arm_group_label>FSMP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nutritional counseling</intervention_name>
      <description>Participant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>FSMP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of non-metastatic ductal breast cancer&#xD;
  &#xD;
            -  Post-menopausal women&#xD;
  &#xD;
            -  Chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide,&#xD;
               scheduled as adjuvant or neo-adjuvant&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Independent oral feeding&#xD;
  &#xD;
            -  Must be able to carry out periodic visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Artificial feeding&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status &gt;2&#xD;
  &#xD;
            -  Impossibility to take the foreseen measurements&#xD;
  &#xD;
            -  Other tumor pathologies&#xD;
  &#xD;
            -  Previous therapy with Doxorubicin or Epirubicin&#xD;
  &#xD;
            -  Ongoing treatment with molecular targeted therapies&#xD;
  &#xD;
            -  Previous chronic renal, hepatic or cardiac insufficiency&#xD;
  &#xD;
            -  History of mental disorders&#xD;
  &#xD;
            -  Known allergies or intolerances to any study product ingredient&#xD;
  &#xD;
            -  Participation in other interventional clinical trials in the past three months&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paolo Pedrazzoli, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paolo Pedrazzoli, MD</last_name>
      <phone>+390382501659</phone>
      <email>p.pedrazzoli@smatteo.pv.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emanuele Cereda, MD</last_name>
      <email>e.cereda@smatteo.pv.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>IRCSS San Matteo University Hospital Foundation</name>
        <address>
          <city>Pavia</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paolo Pedrazzoli, MD</last_name>
        <phone>+390382501659</phone>
        <email>p.pedrazzoli@smatteo.pv.it</email>
      </contact>
      <contact_backup>
        <last_name>Emanuele Cereda, MD</last_name>
        <email>e.cereda@smatteo.pv.it</email>
      </contact_backup>
      <investigator>
        <last_name>Paolo Pedrazzoli, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Riccardo Caccialanza, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Emanuele Cereda, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Elisa Ferraris, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lorenzo Perrone, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Valentina Da Prat, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>flavonoids</keyword>
    <keyword>aminoacids</keyword>
    <keyword>nutrition</keyword>
    <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>
  
  
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/NCT05968677
  org study id: SELECT-BC
  nct id: NCT05968677
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effect of a Food for Special Medical
        Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional
        counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status
        and quality of life in patients with breast cancer.
  
        The main questions it aims to answer are:
  
          -  can this dietary supplementation affect the nutritional status of breast cancer
             patients?
  
          -  can this dietary supplementation have any beneficial effect on chemotoxicity?
             Participants will be asked to undergo nutritional counseling and to take the study
             product every day for 12 weeks.
  
        Researchers will compare a similar group of participants only receiving the nutritional
        counseling to see if any difference occurs.
  Participants will be selected at the first oncological visit at the Outpatient Clinics or the
        Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor,
        evaluated the inclusion and exclusion criteria, will propose patient to participate in the
        study and, after obtaining informed consent, will proceed with enrollment. On the first day
        of chemotherapy, participants will undergo an oncological and nutritional examination, with
        collection of anthropometric data, assessment of body composition, assessment of quality of
        life through special validated questionnaires, blood sampling for blood chemistry tests and
        urine collection. Participants in the treated group will receive a supply of the FSMP to take
        home. At check-up visits, the participant's nutritional status and any adverse events will be
        assessed, other than adherence to treatment by delivery of empty product boxes and
        chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first
        chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
  time frame: 0, 6, 12 weeks
  description: The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
  measure: Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)
  time frame: 0, 3, 6, 9, 12 weeks
  description: Participant's weight in kilograms and height in meters will be combined to report BMI and FFMI in kg/m^2
  measure: Mean change from baseline in Phase Angle
  time frame: 0, 3, 6, 9, 12 weeks
  description: Participant's body composition will be evaluated through measurement of the phase angle which represents the relationship between resistance and capacitive reactance of the body and bioimpedance diagnostics
  measure: Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)
  time frame: 0, 3, 6, 9, 12 weeks
  description: Participant's water and nutritional status will be evaluated
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  time frame: 3, 6, 9, 12 weeks
  description: Proportion of participants with adverse events of any type and specifically haematological, cardiac, gastrointestinal, hepatobiliary, metabolic, psychiatric, renal and urinary types, distinguishing between grade 1-2, grade 3-4 and grade 5.
  Furthermore, the proportion of participants who discontinue chemotherapy treatment and the change in the number of participants who reduce their chemotherapy dose during the treatment
  measure: Mean change from baseline in Interleukine-6 levels
  time frame: 0, 6, 12 weeks
  description: The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
  measure: Mean change from baseline Interleukine-1 beta levels
  time frame: 0, 6, 12 weeks
  description: The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
  measure: Mean change from baseline in C-reactive Protein levels
  time frame: 0, 6, 12 weeks
  description: The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
  measure: Participant's perception of her physical and mental state
  time frame: 0, 12 weeks
  description: Comparison of the total average values resulting from the compilation of two validated oncological questionnaires, which include questions with scores from 1 to 4, where in general higher scores mean a worse outcome
  arm group label: FSMP
  arm group type: Experimental
  description: Nutritional counseling plus one sachet of the study product (6.5 g) per day, away from meals, starting the day after the first chemotherapy cycle until three weeks after the last chemotherapy cycle (for a total of 12 weeks)
  arm group label: Control
  arm group type: Other
  description: Nutritional counseling
  intervention type: Dietary Supplement
  intervention name: FSMP
  description: Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy
  arm group label: FSMP
  intervention type: Other
  intervention name: Nutritional counseling
  description: Participant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled
  arm group label: Control
  arm group label: FSMP
  criteria: 
  gender: Female
  minimum age: 50 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Paolo Pedrazzoli, MD
  role: Principal Investigator
  affiliation: Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation
  last name: Paolo Pedrazzoli, MD
  phone: +390382501659
  email: p.pedrazzoli@smatteo.pv.it
  last name: Emanuele Cereda, MD
  email: e.cereda@smatteo.pv.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Breast Neoplasms