<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/NCT01720563</url>
  </required_header>
  <id_info>
    <org_study_id>PH-CP021</org_study_id>
    <nct_id>NCT01720563</nct_id>
  </id_info>
  <brief_title>A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy</brief_title>
  <official_title>A Phase II Double-blind and Randomized Trial Comparing Concurrent Chemoradiotherapy Plus PG2 Injection Versus Concurrent Chemoradiotherapy Plus Placebo in Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were&#xD;
      betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization&#xD;
      (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was&#xD;
      higher than the 8-11% reported in the Western populations and was related to oral submucous&#xD;
      fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in&#xD;
      patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with&#xD;
      cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in&#xD;
      stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced&#xD;
      myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced&#xD;
      cancer patients. This study will be investigated the effect of PG2 Injection in relieving the&#xD;
      adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis,&#xD;
      body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of&#xD;
      patients with advanced pharyngeal or laryngeal SCCHN.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change study drug dosage form&#xD;
  </why_stopped>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue status by Brief Fatigue Inventory (BFI)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&amp;N 35 questionnaires</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky Performance Scale (KPS)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidences of myelosuppression</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum inflammatory cytokines and c-reactive protein</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Cancer-related Fatigue</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Astragalus polysaccharides 500 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 during the CCRT</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>PG2 Injection 500 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of squamous cell carcinoma&#xD;
&#xD;
          -  Primary tumor site in the head and neck area&#xD;
&#xD;
          -  Stage III or IV disease&#xD;
&#xD;
          -  Measurable locoregional disease and no distant metastasis&#xD;
&#xD;
          -  No prior cancer treatment&#xD;
&#xD;
          -  20-70 years old&#xD;
&#xD;
          -  KPS ≧ 70&#xD;
&#xD;
          -  Adequate bone marrow, liver, and renal function&#xD;
&#xD;
          -  Fed with gastric tubes but without intestinal malabsorption or obstruction&#xD;
&#xD;
          -  Not pregnancy and use a reliable contraceptive method during the study&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Willing and able to complete quality of life questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decompensated liver function&#xD;
&#xD;
          -  Serious concomitant illness that might be aggravated by chemotherapy&#xD;
&#xD;
          -  Active cardiac disease preceding the entry into the study&#xD;
&#xD;
          -  Severe uncontrolled hypertension&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
&#xD;
          -  History of other malignancy&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Receiving other concomitant chemotherapy, radiotherapy or any other anticancer&#xD;
             treatment&#xD;
&#xD;
          -  Mental status not suitable for clinical trials&#xD;
&#xD;
          -  Intestinal obstruction or malabsorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung-Ming HM Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</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>astragalus polysaccharides</keyword>
  <keyword>concurrent chemoradiotherapy</keyword>
  <keyword>squamous cell carcinoma of head and neck</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Tegafur</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01720563
org study id: PH-CP021
nct id: NCT01720563
lead sponsor: 
has dmc: No
Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were
      betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization
      (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was
      higher than the 8-11% reported in the Western populations and was related to oral submucous
      fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in
      patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with
      cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in
      stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced
      myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced
      cancer patients. This study will be investigated the effect of PG2 Injection in relieving the
      adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis,
      body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of
      patients with advanced pharyngeal or laryngeal SCCHN.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fatigue status by Brief Fatigue Inventory (BFI)
time frame: 8 weeks
measure: Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires
time frame: 8 weeks
measure: Karnofsky Performance Scale (KPS)
time frame: 8 weeks
measure: Incidences of myelosuppression
time frame: 8 weeks
measure: Serum inflammatory cytokines and c-reactive protein
time frame: 8 weeks
measure: Weight loss
time frame: 8 weeks
measure: Incidence of adverse events
time frame: 8 weeks
measure: Tumor response
time frame: 8 weeks
arm group label: Control
arm group type: Placebo Comparator
description: Placebo
arm group label: Treatment
arm group type: Experimental
description: Astragalus polysaccharides 500 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 during the CCRT
arm group label: Treatment
other name: PG2 Injection 500 mg
intervention type: Drug
intervention name: Placebo
description: 500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
arm group label: Control
intervention type: Procedure
intervention name: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
arm group label: Control
arm group label: Treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hung-Ming HM Wang, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Fatigue
mesh term: Leucovorin
mesh term: Tegafur