<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/NCT04474951</url>
  </required_header>
  <id_info>
    <org_study_id>GALENO 1</org_study_id>
    <nct_id>NCT04474951</nct_id>
  </id_info>
  <brief_title>Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies</brief_title>
  <acronym>GALENO 1</acronym>
  <official_title>Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</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>
      The main purpose of this study is to evaluate the impact of food supplements (herbal&#xD;
      remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for&#xD;
      improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea.&#xD;
      Secondary aims of the trial are to evaluate the impact of these supplements on the quality of&#xD;
      life and to evaluate their tolerability profile.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Anemia</measure>
    <time_frame>Patients will be followed from date of enrollment for a maximum period of 6 months. Hemoglobin levels monitoring performed for a maximum period of 6 months or until the worsening of anemia (Hb&lt;10 g/dL).</time_frame>
    <description>Assessment of hemoglobin levels every 4 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Patients will be followed from date of enrollment for a maximum period of 6 months.</time_frame>
    <description>Evaluation of fatigue with questionnaire &quot;Brief Fatigue Inventory&quot; - BFI, completed by the patients at day 1 of every cycle of chemotherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nausea</measure>
    <time_frame>Patients will be followed from date of enrollment for a maximum period of 6 months.</time_frame>
    <description>Evaluation of nausea with questionnaire &quot;Multinational Association of Supportive Care in Cancer&quot; - MAT, completed by the patients at day 2 and day 5 of every cycle of chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life level: questionnaire</measure>
    <time_frame>Patients will be followed from date of enrollment for a maximum period of 6 months.</time_frame>
    <description>Evaluation of quality of life with questionnaire EQ-5D, completed at day 1 of every cycle of chemotherapy by patients enrolled in the three arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability of food supplements</measure>
    <time_frame>Patients will be followed from date of enrollment for a maximum period of 6 months.</time_frame>
    <description>Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Anemia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fatigue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nausea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Stinging Nettle</intervention_name>
    <description>Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.</description>
    <arm_group_label>Anemia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Stinging Nettle</intervention_name>
    <description>Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.</description>
    <arm_group_label>Fatigue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Peppermint</intervention_name>
    <description>Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.</description>
    <arm_group_label>Nausea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female ≥ 18 years&#xD;
&#xD;
          -  Karnofsky Performance Scale (KPS) ≥ 90%&#xD;
&#xD;
          -  Breast or Gynecological cancer&#xD;
&#xD;
          -  Informed consent signed before every procedure study specific, on day 1 of therapy&#xD;
             cycle&#xD;
&#xD;
          -  Inclusion Criteria Arm 1: presence of grade 1 anemia as per CTCAE 4.0 criteria;&#xD;
             patients on treatment with anti-CDK 4/6 or PARP Inhibitors or in adjuvant therapy with&#xD;
             hormone therapy&#xD;
&#xD;
          -  Inclusion Criteria Arm 2: presence of fatigue of any grade; patients on treatment with&#xD;
             Epirubicin and Cyclophosphamide or Carboplatin and Taxane&#xD;
&#xD;
          -  Inclusion Criteria Arm 3: presence of nausea of any grade, without vomiting; patients&#xD;
             on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment&#xD;
&#xD;
          -  Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical&#xD;
             hypothyroidism not compensated by replacement therapy; Persistent insomnia&#xD;
&#xD;
          -  Arm 3: patients with evidence of anxiety or anxious-depressive syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Zamagni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudio Zamagni, MD</last_name>
    <phone>051 2144548</phone>
    <phone_ext>+39</phone_ext>
    <email>zamagniclaudio.sper@aosp.bo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudio Zamagni, MD</last_name>
      <phone>051 2144548</phone>
      <phone_ext>+39</phone_ext>
      <email>zamagniclaudio.sper@aosp.bo.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31.</citation>
    <PMID>23390455</PMID>
  </reference>
  <reference>
    <citation>Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16.</citation>
    <PMID>26904610</PMID>
  </reference>
  <reference>
    <citation>Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263.</citation>
    <PMID>14716106</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Claudio Zamagni MD</investigator_full_name>
    <investigator_title>MD Medical Oncologist</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>stinging nettle</keyword>
  <keyword>peppermint</keyword>
  <keyword>anemia</keyword>
  <keyword>fatigue</keyword>
  <keyword>nausea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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>


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/NCT04474951
org study id: GALENO 1
nct id: NCT04474951
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate the impact of food supplements (herbal
      remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for
      improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea.
      Secondary aims of the trial are to evaluate the impact of these supplements on the quality of
      life and to evaluate their tolerability profile.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anemia
time frame: Patients will be followed from date of enrollment for a maximum period of 6 months. Hemoglobin levels monitoring performed for a maximum period of 6 months or until the worsening of anemia (Hb<10 g/dL).
description: Assessment of hemoglobin levels every 4 weeks.
measure: Fatigue
time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
description: Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.
measure: Nausea
time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
description: Evaluation of nausea with questionnaire "Multinational Association of Supportive Care in Cancer" - MAT, completed by the patients at day 2 and day 5 of every cycle of chemotherapy.
measure: Quality of life level: questionnaire
time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
description: Evaluation of quality of life with questionnaire EQ-5D, completed at day 1 of every cycle of chemotherapy by patients enrolled in the three arms.
measure: Tolerability of food supplements
time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
description: Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.
arm group label: Anemia
arm group type: Experimental
description: Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.
arm group label: Fatigue
arm group type: Experimental
description: Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.
arm group label: Nausea
arm group type: Experimental
description: 20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.
intervention type: Dietary Supplement
intervention name: Stinging Nettle
description: Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
arm group label: Anemia
intervention type: Dietary Supplement
intervention name: Stinging Nettle
description: Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
arm group label: Fatigue
intervention type: Dietary Supplement
intervention name: Peppermint
description: Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
arm group label: Nausea
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudio Zamagni, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
last name: Claudio Zamagni, MD
phone: 051 2144548
phone ext: +39
email: zamagniclaudio.sper@aosp.bo.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31.
PMID: 23390455
citation: Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16.
PMID: 26904610
citation: Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263.
PMID: 14716106
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Claudio Zamagni MD
investigator title: MD Medical Oncologist
mesh term: Breast Neoplasms
sharing ipd: No