<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/NCT01720550</url>
  </required_header>
  <id_info>
    <org_study_id>PH-CP012 (II)</org_study_id>
    <nct_id>NCT01720550</nct_id>
  </id_info>
  <brief_title>PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care</brief_title>
  <official_title>PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhytoHealth Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhytoHealth Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to conduct a trial in the spirit of providing as much as&#xD;
      possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and&#xD;
      safety of different doses of PG2 treatment for relieving fatigue among advanced cancer&#xD;
      patients who are under standard palliative care (SPC) at hospice setting and have no further&#xD;
      curative options available. Patient's fatigue status, to be measured by the Brief Fatigue&#xD;
      Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement&#xD;
      response rate among patients between two study arms will then be compared as the basis for&#xD;
      efficacy evaluation at the end of the first treatment cycle, and will be the primary&#xD;
      endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores&#xD;
      change from baseline among patients within and between cycles will be included in the&#xD;
      secondary efficacy endpoints, and will be compared between two study arms. Patients' quality&#xD;
      of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be&#xD;
      also measured by 11 questions (SS11) from EORTC(European Organization) for Research and&#xD;
      Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints&#xD;
      include Karnofsky performance scores, and weight change and its related c-reactive protein&#xD;
      level of the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a trial to evaluate use of different doses of PG2 treatment for fatigue improvement&#xD;
      in advanced cancer patients who are under standard palliative care at hospice setting and&#xD;
      have no further curative options available. Only patients who give consent to participate in&#xD;
      this study and meet all other inclusion and exclusion criteria will be eligible to enroll&#xD;
      into this study. All patients will continue the standard palliative care (SPC) during this&#xD;
      study.&#xD;
&#xD;
      The main aim of this trial is to compare improvement of patient's fatigue status between&#xD;
      patients with different doses of PG2 treatment. Patient's fatigue status will be assessed by&#xD;
      the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement&#xD;
      response will be defined as an improvement in the mean fatigue scores by at least 10% from&#xD;
      baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the&#xD;
      EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related&#xD;
      c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 High&#xD;
      Dose arm; and 2) the PG2 Low Dose arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Improvement Response Rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patient's fatigue status will be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T). The fatigue improvement response rate among patients between two study arms will be compared as the basis for efficacy evaluation at the end of the first treatment cycle (4th week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The fatigue improvement response rate among patients within and between cycles (by BFI-T)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and Quality of Life Assessments: SS11 from EORTC QLQ-C30 (including the evaluation of the quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky performance score</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between Weight change and the related blood c-reactive protein level</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Examination</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Labolatory Safety Examination</measure>
    <time_frame>8 weeks</time_frame>
    <description>Included hematological, biochemical and urine examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune Biomarkers</measure>
    <time_frame>8 weeks</time_frame>
    <description>This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">323</enrollment>
  <condition>Cancer-related Fatigue</condition>
  <arm_group>
    <arm_group_label>PG2 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Astragalus Polysaccharides 500 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PG2 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Astragalus Polysaccharides 250 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Astragalus Polysaccharides 500 mg</intervention_name>
    <description>PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)</description>
    <arm_group_label>PG2 High Dose</arm_group_label>
    <other_name>PG2 Injection 500 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Astragalus Polysaccharides 250 mg</intervention_name>
    <description>PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)</description>
    <arm_group_label>PG2 Low Dose</arm_group_label>
    <other_name>PG2 Injection 250 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed the informed consent form&#xD;
&#xD;
          -  ≧ 20 years old&#xD;
&#xD;
          -  Have locally advanced or metastatic cancer or inoperable advanced cancer&#xD;
&#xD;
          -  Under standard palliative care (SPC) at hospice setting and have no further curative&#xD;
             options available&#xD;
&#xD;
          -  BFI score ≧ 4&#xD;
&#xD;
          -  Life expectancy of at least 3 months as determined by the investigator&#xD;
&#xD;
          -  Willing and able to complete quality of life questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Uncontrolled systemic disease&#xD;
&#xD;
          -  Take central nervous system stimulators within 30 days before screening&#xD;
&#xD;
          -  Have enrolled or have not yet completed other investigational drug trials within 30&#xD;
             days before screening&#xD;
&#xD;
          -  Karnofsky Performance Scores less than 30 %&#xD;
&#xD;
          -  Diagnosed as dying status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuen-Liang YL Lai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Kaohsiung Branch</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Lakeview Branch</name>
      <address>
        <city>Keelung City</city>
        <zip>204</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital, Loiuying Campus</name>
      <address>
        <city>Tainan</city>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University -Shung Ho Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>235</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer-related fatigue</keyword>
  <keyword>Palliative Treatment</keyword>
  <keyword>Astragalus polysaccharides</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01720550
org study id: PH-CP012 (II)
nct id: NCT01720550
lead sponsor: 
has dmc: Yes
The objective of this study is to conduct a trial in the spirit of providing as much as
      possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and
      safety of different doses of PG2 treatment for relieving fatigue among advanced cancer
      patients who are under standard palliative care (SPC) at hospice setting and have no further
      curative options available. Patient's fatigue status, to be measured by the Brief Fatigue
      Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement
      response rate among patients between two study arms will then be compared as the basis for
      efficacy evaluation at the end of the first treatment cycle, and will be the primary
      endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores
      change from baseline among patients within and between cycles will be included in the
      secondary efficacy endpoints, and will be compared between two study arms. Patients' quality
      of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be
      also measured by 11 questions (SS11) from EORTC(European Organization) for Research and
      Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints
      include Karnofsky performance scores, and weight change and its related c-reactive protein
      level of the patients.
This is a trial to evaluate use of different doses of PG2 treatment for fatigue improvement
      in advanced cancer patients who are under standard palliative care at hospice setting and
      have no further curative options available. Only patients who give consent to participate in
      this study and meet all other inclusion and exclusion criteria will be eligible to enroll
      into this study. All patients will continue the standard palliative care (SPC) during this
      study.

      The main aim of this trial is to compare improvement of patient's fatigue status between
      patients with different doses of PG2 treatment. Patient's fatigue status will be assessed by
      the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement
      response will be defined as an improvement in the mean fatigue scores by at least 10% from
      baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the
      EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related
      c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 High
      Dose arm; and 2) the PG2 Low Dose arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fatigue Improvement Response Rate
time frame: 4 weeks
description: Patient's fatigue status will be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T). The fatigue improvement response rate among patients between two study arms will be compared as the basis for efficacy evaluation at the end of the first treatment cycle (4th week).
measure: The fatigue improvement response rate among patients within and between cycles (by BFI-T)
time frame: 8 weeks
measure: The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms
time frame: 8 weeks
measure: The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)
time frame: 8 weeks
measure: Symptoms and Quality of Life Assessments: SS11 from EORTC QLQ-C30 (including the evaluation of the quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life)
time frame: 8 weeks
measure: Karnofsky performance score
time frame: 8 weeks
measure: The correlation between Weight change and the related blood c-reactive protein level
time frame: 8 weeks
measure: Physical Examination
time frame: 8 weeks
measure: Labolatory Safety Examination
time frame: 8 weeks
description: Included hematological, biochemical and urine examination
measure: Incidence of Adverse Events as a Measure of Safety and Tolerability
time frame: 8 weeks
measure: Vital signs
time frame: 8 weeks
measure: Immune Biomarkers
time frame: 8 weeks
description: This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)
arm group label: PG2 High Dose
arm group type: Experimental
description: Astragalus Polysaccharides 500 mg
arm group label: PG2 Low Dose
arm group type: Experimental
description: Astragalus Polysaccharides 250 mg
intervention type: Drug
intervention name: Astragalus Polysaccharides 500 mg
description: PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
arm group label: PG2 High Dose
other name: PG2 Injection 500 mg
intervention type: Drug
intervention name: Astragalus Polysaccharides 250 mg
description: PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
arm group label: PG2 Low Dose
other name: PG2 Injection 250 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yuen-Liang YL Lai, MD
role: Principal Investigator
affiliation: Mackay Memorial Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: Undecided