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/NCT06023420</url>
    </required_header>
    <id_info>
      <org_study_id>2021.746-T</org_study_id>
      <nct_id>NCT06023420</nct_id>
    </id_info>
    <brief_title>Efficacy of a Herbal Formula for Bone Metastases</brief_title>
    <official_title>Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</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>
        RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications&#xD;
        collectively termed skeletal-related events (SREs). The study herbal medicine might reduce&#xD;
        the morbidities due to &quot;Skeletal-related events&quot; (SRES), and extend survival time.&#xD;
  &#xD;
        PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of&#xD;
        &quot;Skeletal-related events&quot; (SRES), and survival time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OBJECTIVES:&#xD;
  &#xD;
        Primary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival&#xD;
        rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of&#xD;
        Life: EQ5-D Pain control (Brief Pain Inventory)&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone&#xD;
        after all the eligibility criteria have been fulfilled and informed consent has been signed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</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>reducing the morbidities of &quot;Skeletal-related events&quot; (SRES) extending survival time</measure>
      <time_frame>3 months</time_frame>
      <description>SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival rate and survival time</measure>
      <time_frame>Proportion of participants in all groups with overall survival at 1 year</time_frame>
      <description>Proportion of participants in each group with overall survival at 6 months</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Bone Metastases</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Herbal formula 5g daily, and Zometa</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Zometa alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>4 Herbs Formula</intervention_name>
      <description>4 herbs formula dose: 5g/day</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
      <other_name>Zometa</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 years or older&#xD;
  &#xD;
            -  Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone&#xD;
  &#xD;
            -  Confirmed diagnosis of metastatic breast cancer&#xD;
  &#xD;
            -  Radiographic proof of metastatic bone disease&#xD;
  &#xD;
            -  Informed consent obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known history of primary bone tumors (benign and/or malignant)&#xD;
  &#xD;
            -  Prior use of bone modifying agents, including but not limited to zoledronic acid or&#xD;
               denosumab within 12 months of study entry&#xD;
  &#xD;
            -  Active anti-cancer therapies in the form of cytotoxics or targeted therapies.&#xD;
               [Patients who are currently on hormonal therapies, including but not limited to&#xD;
               tamoxifen, aromatase inhibitors and LHRH agonists/antagonists are allowed for study&#xD;
               entry. Clarifications shall be sought from investigators if in doubt].&#xD;
  &#xD;
            -  Significant drug hypersensitivity&#xD;
  &#xD;
            -  No informed consent signed&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Cheng King Fai</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>Neoplasm Metastasis</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/NCT06023420
  org study id: 2021.746-T
  nct id: NCT06023420
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications
        collectively termed skeletal-related events (SREs). The study herbal medicine might reduce
        the morbidities due to "Skeletal-related events" (SRES), and extend survival time.
  
        PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of
        "Skeletal-related events" (SRES), and survival time.
  OBJECTIVES:
  
        Primary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival
        rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of
        Life: EQ5-D Pain control (Brief Pain Inventory)
  
        OUTLINE:
  
        Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone
        after all the eligibility criteria have been fulfilled and informed consent has been signed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
  time frame: 3 months
  description: SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).
  measure: Survival rate and survival time
  time frame: Proportion of participants in all groups with overall survival at 1 year
  description: Proportion of participants in each group with overall survival at 6 months
  arm group label: Study group
  arm group type: Experimental
  description: Herbal formula 5g daily, and Zometa
  arm group label: Control group
  arm group type: Active Comparator
  description: Zometa alone
  intervention type: Drug
  intervention name: 4 Herbs Formula
  description: 4 herbs formula dose: 5g/day
  arm group label: Control group
  arm group label: Study group
  other name: Zometa
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Cheng King Fai
  investigator title: Principal Investigator
  mesh term: Neoplasm Metastasis