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/NCT06018896</url>
    </required_header>
    <id_info>
      <org_study_id>PTCA199-4</org_study_id>
      <nct_id>NCT06018896</nct_id>
    </id_info>
    <brief_title>Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer</brief_title>
    <acronym>PTCA199-4</acronym>
    <official_title>Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</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 purpose of this study is to evaluate the efficacy of vitamin C in improving the quality&#xD;
        of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.&#xD;
        Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.&#xD;
        Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, a trial&#xD;
        has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was&#xD;
        associated with a survival advantage but had increased toxicity. In 2013, the Metastatic&#xD;
        PAncreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with&#xD;
        nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the&#xD;
        side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue, nausea,&#xD;
        and malnutrition have impaired the quality of life for patients.&#xD;
  &#xD;
        Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates&#xD;
        metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown&#xD;
        that high-dose intravenous Vitamin C may be effective against various types of cancer.&#xD;
        Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia,&#xD;
        alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with&#xD;
        terminal stage pancreatic cancer.&#xD;
  &#xD;
        The purpose of this study is to evaluate the efficacy of vitamin C on improving the quality&#xD;
        of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic&#xD;
        chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Twenty&#xD;
        patients who have tumor progression after receiving two lines of chemotherapy will be&#xD;
        recruited. These patients will receive Vitamin C and the dosage is based on the concentration&#xD;
        of baseline serum Vitamin C concentration. Quality of life, rate of hand/foot numbness,&#xD;
        severity of pain, rate of anemia, and overall survival are measured every four weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of life (QOL)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of hand-foot skin reaction (HFSR)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Rate of HFSR after every cycle of treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of numeric rating scale (NRS)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. The range of NRS scale is 0-10 and higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of anemia</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Rate of anemia after every cycle of treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Metastatic Pancreatic Cancer</condition>
    <condition>Terminal Cancer</condition>
    <arm_group>
      <arm_group_label>Ascorbate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For patients with baseline serum Vitamin C concentration &lt; 65 μmol/L, intravenous Vitamin C 10 g × 7 days, intravenous Vitamin C 4 g × 7 days, intravenous Vitamin C 2 g × 7 days, followed by continuously 900 mg/day, three times a day, orally. For patients with baseline serum Vitamin C concentration ≥ 65 μmol/L, continuously 900 mg/day, three times a day, orally.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ascorbate</intervention_name>
      <description>For patients with baseline serum Vitamin C concentration &lt; 65 μmol/L, intravenous Vitamin C 10 g × 7 days, intravenous Vitamin C 4 g × 7 days, intravenous Vitamin C 2 g × 7 days, followed by continuously 900 mg/day, three times a day, orally. For patients with baseline serum Vitamin C concentration ≥ 65 μmol/L, continuously 900 mg/day, three times a day, orally.</description>
      <arm_group_label>Ascorbate</arm_group_label>
      <other_name>Vitamin C</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
  &#xD;
            -  Age ≥ 18 years and ≤ 80 years.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.&#xD;
  &#xD;
            -  Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.&#xD;
  &#xD;
            -  Tumor progression after two lines of chemotherapy.&#xD;
  &#xD;
            -  Adequate organ performance based on laboratory blood tests.&#xD;
  &#xD;
            -  Presence of at least of one measurable lesion in agreement to Response Evaluation&#xD;
               Criteria in Solid Tumours (RECIST) criteria.&#xD;
  &#xD;
            -  The expected survival ≥ 1 months.&#xD;
  &#xD;
            -  Women of childbearing potential and men must agree to use adequate contraception prior&#xD;
               to study entry and for the duration of study participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active second primary malignancy or history of second primary malignancy.&#xD;
  &#xD;
            -  The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.&#xD;
  &#xD;
            -  Inflammation of the digestive tract, including pancreatitis, cholecystitis,&#xD;
               cholangitis, etc.&#xD;
  &#xD;
            -  Pregnant or nursing women.&#xD;
  &#xD;
            -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
  &#xD;
            -  Severe and uncontrollable accompanying diseases that may affect protocol compliance or&#xD;
               interfere with the interpretation of results.&#xD;
  &#xD;
            -  Renal insufficiency or dialysis&#xD;
  &#xD;
            -  Other serious accompanying illnesses, which, in the researcher's opinion, could&#xD;
               seriously adversely affect the safety of the treatment.&#xD;
  &#xD;
            -  Patients who are unwilling or unable to comply with study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guopei Luo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ying Yang, MD</last_name>
      <phone>86 21 64175590</phone>
      <phone_ext>1307</phone_ext>
      <email>yangying@fudanpci.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ying Yang, MD</last_name>
        <phone>86 21 64175590</phone>
        <phone_ext>1307</phone_ext>
        <email>yangying@fudanpci.org</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Guopei Luo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>ascorbate</keyword>
    <keyword>anemia</keyword>
    <keyword>quality of life</keyword>
    <keyword>chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic 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>
  
  
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/NCT06018896
  org study id: PTCA199-4
  nct id: NCT06018896
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of vitamin C in improving the quality
        of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.
  Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.
        Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.
        Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, a trial
        has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was
        associated with a survival advantage but had increased toxicity. In 2013, the Metastatic
        PAncreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with
        nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the
        side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue, nausea,
        and malnutrition have impaired the quality of life for patients.
  
        Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates
        metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown
        that high-dose intravenous Vitamin C may be effective against various types of cancer.
        Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia,
        alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with
        terminal stage pancreatic cancer.
  
        The purpose of this study is to evaluate the efficacy of vitamin C on improving the quality
        of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic
        chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Twenty
        patients who have tumor progression after receiving two lines of chemotherapy will be
        recruited. These patients will receive Vitamin C and the dosage is based on the concentration
        of baseline serum Vitamin C concentration. Quality of life, rate of hand/foot numbness,
        severity of pain, rate of anemia, and overall survival are measured every four weeks.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Quality of life (QOL)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  measure: Rate of hand-foot skin reaction (HFSR)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Rate of HFSR after every cycle of treatment
  measure: Change of numeric rating scale (NRS)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
  measure: Rate of anemia
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Rate of anemia after every cycle of treatment
  measure: Overall survival (OS)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
  arm group label: Ascorbate
  arm group type: Experimental
  description: For patients with baseline serum Vitamin C concentration < 65 μmol/L, intravenous Vitamin C 10 g × 7 days, intravenous Vitamin C 4 g × 7 days, intravenous Vitamin C 2 g × 7 days, followed by continuously 900 mg/day, three times a day, orally. For patients with baseline serum Vitamin C concentration ≥ 65 μmol/L, continuously 900 mg/day, three times a day, orally.
  intervention type: Drug
  intervention name: Ascorbate
  description: For patients with baseline serum Vitamin C concentration < 65 μmol/L, intravenous Vitamin C 10 g × 7 days, intravenous Vitamin C 4 g × 7 days, intravenous Vitamin C 2 g × 7 days, followed by continuously 900 mg/day, three times a day, orally. For patients with baseline serum Vitamin C concentration ≥ 65 μmol/L, continuously 900 mg/day, three times a day, orally.
  arm group label: Ascorbate
  other name: Vitamin C
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guopei Luo, MD
  role: Principal Investigator
  affiliation: Fudan University
  last name: Ying Yang, MD
  phone: 86 21 64175590
  phone ext: 1307
  email: yangying@fudanpci.org
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Guopei Luo
  investigator title: Professor
  mesh term: Pancreatic Neoplasms
  sharing ipd: No