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/NCT06016400</url>
    </required_header>
    <id_info>
      <org_study_id>2021-KY-049</org_study_id>
      <nct_id>NCT06016400</nct_id>
    </id_info>
    <brief_title>Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma</brief_title>
    <official_title>A Randomized, Double-blind, Single-center Clinical Trial of Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial&#xD;
        region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel,&#xD;
        cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the&#xD;
        treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can&#xD;
        significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is&#xD;
        a common side effect during chemotherapy, which seriously affects the quality of life of&#xD;
        chemotherapy patients and may lead to the termination of chemotherapy. Prevention and&#xD;
        treatment of oral mucositis is still an urgent clinical problem. Investigators' previous&#xD;
        studies have found that vitamin D can significantly inhibit the proliferation, migration,&#xD;
        invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect&#xD;
        normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy&#xD;
        drugs. Based on the previous basic research, this project intends to conduct a single-center,&#xD;
        prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in&#xD;
        reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing&#xD;
        TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of&#xD;
        vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy.&#xD;
        The results of this study are expected to serve as guidelines to guide clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 14, 2021</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Phase 2/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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Within two months from the start of chemotherapy</measure>
      <time_frame>Within two months from the start of chemotherapy</time_frame>
      <description>Oral mucosal hyperemia, erythema, erosion, ulceration and fibrosis appear, accompanied by clinical manifestations such as pain, difficulty eating, dry mouth, and taste disturbance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Grading of oral mucositis in patients treated with vitamin D and placebo</measure>
      <time_frame>Within two months from the start of chemotherapy</time_frame>
      <description>According to the American Oncology Nurse Oral Mucositis Evaluation Scale, the score &lt;8 is normal; 9-10 is mild; 11-12 is moderate; &gt;12 is severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the quality of life of patients in vitamin D treatment group and placebo group before</measure>
      <time_frame>Within two months from the start of chemotherapy</time_frame>
      <description>University of Washington quality of life scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healing time of oral mucositis in vitamin D treatment group and placebo group</measure>
      <time_frame>Within two months from the end of chemotherapy</time_frame>
      <description>Time to cure of patients with oral mucositis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay of patients in vitamin D treatment group and placebo group</measure>
      <time_frame>Within two months from the start of chemotherapy</time_frame>
      <description>Length of hospital stay</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">412</enrollment>
    <condition>Oral Squamous Cell Carcinoma</condition>
    <condition>Oral Mucositis</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Alfacalcidol Drops,1ug a day,40day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Alfacalcidol Oral Solution</intervention_name>
      <description>Alfacalcidol Oral Solution 1ug a day</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged 20-70 years&#xD;
  &#xD;
            2. Patients with pathologically diagnosed oral squamous cell carcinoma who need TPF-based&#xD;
               chemotherapy regimens, and whose expected survival time is greater than 6 months&#xD;
  &#xD;
            3. Patients whose serum 25-hydroxyvitamin D level was vitamin D deficiency (&lt;30nmol/L)&#xD;
               and adequate (30-50nmol/L) before chemotherapy&#xD;
  &#xD;
            4. Patients and their families agree to participate in this trial and sign an informed&#xD;
               consent form&#xD;
  &#xD;
            5. No cognitive impairment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. People with oral ulcers or other oral mucosal diseases (such as: oral mucosal&#xD;
               pemphigus, etc.) at the beginning of the study&#xD;
  &#xD;
            2. Patients who are allergic to alfacalcidol drops&#xD;
  &#xD;
            3. Patients with severe cardiac insufficiency, liver and kidney insufficiency, and&#xD;
               systemic infectious diseases&#xD;
  &#xD;
            4. Pregnant women (judged by HCG test) and lactating patients&#xD;
  &#xD;
            5. Participating in other clinical trials during the study&#xD;
  &#xD;
            6. Those who do not understand or cooperate with clinical trials&#xD;
  &#xD;
            7. Patients with hypervitaminosis D, hypercalcemia, hyperphosphatemia and renal rickets&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>zhiquan huang, PH.D</last_name>
        <phone>13826142898</phone>
        <email>hzhquan@mail.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Mucositis</mesh_term>
      <mesh_term>Stomatitis</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alfacalcidol</mesh_term>
      <mesh_term>Hydroxycholecalciferols</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/NCT06016400
  org study id: 2021-KY-049
  nct id: NCT06016400
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial
        region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel,
        cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the
        treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can
        significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is
        a common side effect during chemotherapy, which seriously affects the quality of life of
        chemotherapy patients and may lead to the termination of chemotherapy. Prevention and
        treatment of oral mucositis is still an urgent clinical problem. Investigators' previous
        studies have found that vitamin D can significantly inhibit the proliferation, migration,
        invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect
        normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy
        drugs. Based on the previous basic research, this project intends to conduct a single-center,
        prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in
        reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing
        TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of
        vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy.
        The results of this study are expected to serve as guidelines to guide clinical practice.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Within two months from the start of chemotherapy
  time frame: Within two months from the start of chemotherapy
  description: Oral mucosal hyperemia, erythema, erosion, ulceration and fibrosis appear, accompanied by clinical manifestations such as pain, difficulty eating, dry mouth, and taste disturbance.
  measure: Grading of oral mucositis in patients treated with vitamin D and placebo
  time frame: Within two months from the start of chemotherapy
  description: According to the American Oncology Nurse Oral Mucositis Evaluation Scale, the score <8 is normal; 9-10 is mild; 11-12 is moderate; >12 is severe
  measure: Changes in the quality of life of patients in vitamin D treatment group and placebo group before
  time frame: Within two months from the start of chemotherapy
  description: University of Washington quality of life scale
  measure: Healing time of oral mucositis in vitamin D treatment group and placebo group
  time frame: Within two months from the end of chemotherapy
  description: Time to cure of patients with oral mucositis
  measure: Length of hospital stay of patients in vitamin D treatment group and placebo group
  time frame: Within two months from the start of chemotherapy
  description: Length of hospital stay
  arm group label: intervention group
  arm group type: Experimental
  description: Alfacalcidol Drops,1ug a day,40day
  arm group label: control group
  arm group type: Placebo Comparator
  description: Placebo
  intervention type: Drug
  intervention name: Alfacalcidol Oral Solution
  description: Alfacalcidol Oral Solution 1ug a day
  arm group label: intervention group
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Mucositis
  mesh term: Stomatitis
  mesh term: Inflammation
  mesh term: Alfacalcidol
  mesh term: Hydroxycholecalciferols
  sharing ipd: No