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/NCT06018883</url>
    </required_header>
    <id_info>
      <org_study_id>PTCA199-3</org_study_id>
      <nct_id>NCT06018883</nct_id>
    </id_info>
    <brief_title>Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer</brief_title>
    <acronym>PTCA199-3</acronym>
    <official_title>Vitamin C to Chemotherapy Related Anemia in 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 low-dose vitamin C on improving the&#xD;
        quality of life for metastatic pancreatic cancer patients receiving gemcitabine and&#xD;
        nab-paclitaxel 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. 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 gemcitabine combined with nab-paclitaxel including anemia, hand/foot&#xD;
        numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.&#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 enhance the tolerability of chemotherapy by&#xD;
        increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and&#xD;
        thus improving quality of life for patients with pancreatic cancer.&#xD;
  &#xD;
        The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the&#xD;
        quality of life for metastatic pancreatic cancer patients receiving gemcitabine and&#xD;
        nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the&#xD;
        experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C) or the control group&#xD;
        (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness,&#xD;
        severity of pain, quality of life, and overall survival are measured every four weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_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 chemotherapy</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 chemotherapy</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>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>
    </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>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Metastatic Pancreatic Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Ascorbate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ascorbate</intervention_name>
      <description>Vitamin C 900 mg/day, three times a day, orally.</description>
      <arm_group_label>Ascorbate</arm_group_label>
      <other_name>Vitamin C</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nab paclitaxel</intervention_name>
      <description>Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks</description>
      <arm_group_label>Ascorbate</arm_group_label>
      <arm_group_label>Control</arm_group_label>
      <other_name>Nab-paclitaxel</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks</description>
      <arm_group_label>Ascorbate</arm_group_label>
      <arm_group_label>Control</arm_group_label>
      <other_name>Gemcitabine Hydrochloride</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;
            -  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;
            -  Hemoglobin (Hgb) ≥ 8 g/dL.&#xD;
  &#xD;
            -  The expected survival ≥ 3 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;
            -  Patients who have received any form of anti-tumor therapy.&#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, including active opportunistic&#xD;
               infections or advanced (severe) infections, and diabetes that cannot be controlled&#xD;
               after adequate clinical anti-hyperglycemia treatment according to guidelines,&#xD;
               uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as&#xD;
               defined by the New York Heart Association classification, congestive heart failure&#xD;
               (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable&#xD;
               angina, cerebral infarction within 3 months, etc).&#xD;
  &#xD;
            -  Renal insufficiency or dialysis&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to gemcitabine, nab-paclitaxel, or other agents used in the study.&#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>
    <results_reference>
      <citation>Magri A, Germano G, Lorenzato A, Lamba S, Chila R, Montone M, Amodio V, Ceruti T, Sassi F, Arena S, Abrignani S, D'Incalci M, Zucchetti M, Di Nicolantonio F, Bardelli A. High-dose vitamin C enhances cancer immunotherapy. Sci Transl Med. 2020 Feb 26;12(532):eaay8707. doi: 10.1126/scitranslmed.aay8707.</citation>
      <PMID>32102933</PMID>
    </results_reference>
    <results_reference>
      <citation>Drisko JA, Serrano OK, Spruce LR, Chen Q, Levine M. Treatment of pancreatic cancer with intravenous vitamin C: a case report. Anticancer Drugs. 2018 Apr;29(4):373-379. doi: 10.1097/CAD.0000000000000603.</citation>
      <PMID>29438178</PMID>
    </results_reference>
    <results_reference>
      <citation>Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.</citation>
      <PMID>26201606</PMID>
    </results_reference>
    <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>Anemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_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/NCT06018883
  org study id: PTCA199-3
  nct id: NCT06018883
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the
        quality of life for metastatic pancreatic cancer patients receiving gemcitabine and
        nab-paclitaxel 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. 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 gemcitabine combined with nab-paclitaxel including anemia, hand/foot
        numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
  
        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 enhance the tolerability of chemotherapy by
        increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and
        thus improving quality of life for patients with pancreatic cancer.
  
        The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the
        quality of life for metastatic pancreatic cancer patients receiving gemcitabine and
        nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the
        experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C) or the control group
        (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness,
        severity of pain, quality of life, and overall survival are measured every four weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  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 chemotherapy
  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 chemotherapy
  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: 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: 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: nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.
  arm group label: Control
  arm group type: Other
  description: nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
  intervention type: Drug
  intervention name: Ascorbate
  description: Vitamin C 900 mg/day, three times a day, orally.
  arm group label: Ascorbate
  other name: Vitamin C
  intervention type: Drug
  intervention name: Nab paclitaxel
  description: Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
  arm group label: Ascorbate
  arm group label: Control
  other name: Nab-paclitaxel
  intervention type: Drug
  intervention name: Gemcitabine
  description: Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
  arm group label: Ascorbate
  arm group label: Control
  other name: Gemcitabine Hydrochloride
  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
  citation: Magri A, Germano G, Lorenzato A, Lamba S, Chila R, Montone M, Amodio V, Ceruti T, Sassi F, Arena S, Abrignani S, D'Incalci M, Zucchetti M, Di Nicolantonio F, Bardelli A. High-dose vitamin C enhances cancer immunotherapy. Sci Transl Med. 2020 Feb 26;12(532):eaay8707. doi: 10.1126/scitranslmed.aay8707.
  PMID: 32102933
  citation: Drisko JA, Serrano OK, Spruce LR, Chen Q, Levine M. Treatment of pancreatic cancer with intravenous vitamin C: a case report. Anticancer Drugs. 2018 Apr;29(4):373-379. doi: 10.1097/CAD.0000000000000603.
  PMID: 29438178
  citation: Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.
  PMID: 26201606
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Guopei Luo
  investigator title: Professor
  mesh term: Anemia
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel
  mesh term: Gemcitabine
  sharing ipd: No