<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/NCT03292822</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-26</org_study_id>
    <nct_id>NCT03292822</nct_id>
  </id_info>
  <brief_title>Effects of (Licochalcone A) and Paclitaxel on Human Oral Squamous Cell Carcinoma Cell Line</brief_title>
  <official_title>Apoptotic and Anti-Proliferative Effects of Licorice Extract (Licochalcone A) and Paclitaxel Chemotherapy on Human Oral Squamous Cell Carcinoma Cell Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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 (OSCC) are considered as a one of the most malignant cancers. It&#xD;
      has prognosis due to its distant metastasis and obvious destruction which lead to low&#xD;
      survival rate.&#xD;
&#xD;
      The conventional treatment modalities such as surgery, radiotherapy and chemotherapy are only&#xD;
      the suitable strategies until now. Investigators cannot ignore the serious side effects of&#xD;
      chemotherapy such as gastrointestinal upset, bone marrow suppression which cannot be&#xD;
      overcome. For all these complications, there is a great need and demand to discover a new&#xD;
      agents and strategies for treating OSCC.&#xD;
&#xD;
      Licorice extract, especially Licochalcone A, is one of many natural extracts that have used&#xD;
      as a traditional in treatment of inflammation, microbial infections. Regarding antitumor&#xD;
      effect, Licochalcone A reveals interesting results in programmed cell death and apoptosis in&#xD;
      cancer cells such as prostate, bladder, colon and gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral squamous cell carcinoma (OSCC) is considered the most common human body malignant tumor.&#xD;
      It has poor prognosis regarding its distant lymph node metastasis and local destruction which&#xD;
      lead to low survival rate.&#xD;
&#xD;
      Paclitaxel is a chemotherapeutic drug of the taxols group that is used in the treatment of&#xD;
      lung, ovarian and prostate cancer. It is also used to treat breast, head and neck cancer as&#xD;
      well as sarcoma and leukemia. Recent studies and researches explored that Paclitaxel has an&#xD;
      important role in mitotic arrest activation and induction, which subsequently lead to cell&#xD;
      death.&#xD;
&#xD;
      The conventional treatment strategies such as surgery, radiotherapy and chemotherapy come&#xD;
      with low levels of expectations regarding prognosis and survival rate. On the other hand,&#xD;
      serious side effects of chemotherapy such as renal toxicity, gastrointestinal upset and bone&#xD;
      marrow suppression remain hazards which cannot be avoided.Thus, there is a great need to&#xD;
      discover new agents and strategies for treating OSCC or even enhancing the effect of&#xD;
      chemotherapy in order to reduce the dose given.&#xD;
&#xD;
      Licorice extract, Licochalcone A, is one of many natural extracts of Glycyrrhiza inflata&#xD;
      plant. It has been used in treatment of inflammation, infections and cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apoptosis</measure>
    <time_frame>3 days</time_frame>
    <description>programmed cell death</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Licochalcone A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>chemotherapeutic drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Licochalcone A</intervention_name>
    <description>Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties in vitro.</description>
    <arm_group_label>Licochalcone A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>chemotherapeutic drug</description>
    <arm_group_label>Paclitaxel</arm_group_label>
    <other_name>taxol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All head and neck squamous cell carcinoma cell lines&#xD;
&#xD;
          2. Licochalcone extracts&#xD;
&#xD;
          3. Taxols group of chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Animal experimental studies&#xD;
&#xD;
          2. Any cancer cell line other than squamous cell carcinoma cell lines.&#xD;
&#xD;
          3. Any chemotherapeutics other than Taxols group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed H El-Khadem, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mohamed O Mostafa, master</last_name>
    <phone>00201061228307</phone>
    <email>mosomadent@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Park MR, Kim SG, Cho IA, Oh D, Kang KR, Lee SY, Moon SM, Cho SS, Yoon G, Kim CS, Oh JS, You JS, Kim DK, Seo YS, Im HJ, Kim JS. Licochalcone-A induces intrinsic and extrinsic apoptosis via ERK1/2 and p38 phosphorylation-mediated TRAIL expression in head and neck squamous carcinoma FaDu cells. Food Chem Toxicol. 2015 Mar;77:34-43. doi: 10.1016/j.fct.2014.12.013. Epub 2015 Jan 5.</citation>
    <PMID>25572524</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Moahmed Osama mostafa</investigator_full_name>
    <investigator_title>teaching assistant</investigator_title>
  </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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03292822/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03292822
org study id: CEBD-CU-2017-09-26
nct id: NCT03292822
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Oral squamous cell carcinoma (OSCC) are considered as a one of the most malignant cancers. It
      has prognosis due to its distant metastasis and obvious destruction which lead to low
      survival rate.

      The conventional treatment modalities such as surgery, radiotherapy and chemotherapy are only
      the suitable strategies until now. Investigators cannot ignore the serious side effects of
      chemotherapy such as gastrointestinal upset, bone marrow suppression which cannot be
      overcome. For all these complications, there is a great need and demand to discover a new
      agents and strategies for treating OSCC.

      Licorice extract, especially Licochalcone A, is one of many natural extracts that have used
      as a traditional in treatment of inflammation, microbial infections. Regarding antitumor
      effect, Licochalcone A reveals interesting results in programmed cell death and apoptosis in
      cancer cells such as prostate, bladder, colon and gastric cancer.
Oral squamous cell carcinoma (OSCC) is considered the most common human body malignant tumor.
      It has poor prognosis regarding its distant lymph node metastasis and local destruction which
      lead to low survival rate.

      Paclitaxel is a chemotherapeutic drug of the taxols group that is used in the treatment of
      lung, ovarian and prostate cancer. It is also used to treat breast, head and neck cancer as
      well as sarcoma and leukemia. Recent studies and researches explored that Paclitaxel has an
      important role in mitotic arrest activation and induction, which subsequently lead to cell
      death.

      The conventional treatment strategies such as surgery, radiotherapy and chemotherapy come
      with low levels of expectations regarding prognosis and survival rate. On the other hand,
      serious side effects of chemotherapy such as renal toxicity, gastrointestinal upset and bone
      marrow suppression remain hazards which cannot be avoided.Thus, there is a great need to
      discover new agents and strategies for treating OSCC or even enhancing the effect of
      chemotherapy in order to reduce the dose given.

      Licorice extract, Licochalcone A, is one of many natural extracts of Glycyrrhiza inflata
      plant. It has been used in treatment of inflammation, infections and cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Apoptosis
time frame: 3 days
description: programmed cell death
arm group label: Licochalcone A
arm group type: Experimental
description: Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties.
arm group label: Paclitaxel
arm group type: Active Comparator
description: chemotherapeutic drug
intervention type: Dietary Supplement
intervention name: Licochalcone A
description: Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties in vitro.
arm group label: Licochalcone A
intervention type: Drug
intervention name: Paclitaxel
description: chemotherapeutic drug
arm group label: Paclitaxel
other name: taxol
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmed H El-Khadem, Phd
role: Study Chair
affiliation: Cairo University
last name: mohamed O Mostafa, master
phone: 00201061228307
email: mosomadent@gmail.com
facility: 
country: Egypt
citation: Park MR, Kim SG, Cho IA, Oh D, Kang KR, Lee SY, Moon SM, Cho SS, Yoon G, Kim CS, Oh JS, You JS, Kim DK, Seo YS, Im HJ, Kim JS. Licochalcone-A induces intrinsic and extrinsic apoptosis via ERK1/2 and p38 phosphorylation-mediated TRAIL expression in head and neck squamous carcinoma FaDu cells. Food Chem Toxicol. 2015 Mar;77:34-43. doi: 10.1016/j.fct.2014.12.013. Epub 2015 Jan 5.
PMID: 25572524
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Moahmed Osama mostafa
investigator title: teaching assistant
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Paclitaxel
provided document: 