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Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

Primary Purpose

Tongue Neoplasms, Carcinoma

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
luteolin
nano-luteolin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tongue Neoplasms focused on measuring TSCC, OSCC, luteolin, nanoluteolin, nanotechnology, oral cancer, apoptosis, PCR, MTT, ELISA reader

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).
  • Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).
  • Application of luteolin as a chemotherapeutic drug.

Exclusion Criteria:

  • Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
  • Luteolin glycosides.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    luteolin

    nano-luteolin

    Arm Description

    a natural extract derived flavinoids

    nano-particles derived from a natural extract luteolin

    Outcomes

    Primary Outcome Measures

    gene expression of Caspase 3 to detect apoptosis
    fold-changes

    Secondary Outcome Measures

    cell viability
    micromolar

    Full Information

    First Posted
    September 12, 2017
    Last Updated
    September 18, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03288298
    Brief Title
    Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line
    Official Title
    Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2017 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    April 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.
    Detailed Description
    This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tongue Neoplasms, Carcinoma
    Keywords
    TSCC, OSCC, luteolin, nanoluteolin, nanotechnology, oral cancer, apoptosis, PCR, MTT, ELISA reader

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    luteolin
    Arm Type
    Experimental
    Arm Description
    a natural extract derived flavinoids
    Arm Title
    nano-luteolin
    Arm Type
    Active Comparator
    Arm Description
    nano-particles derived from a natural extract luteolin
    Intervention Type
    Drug
    Intervention Name(s)
    luteolin
    Other Intervention Name(s)
    3',4',5,7-tetrahydroxyflavone
    Intervention Description
    flavonoid natural extract
    Intervention Type
    Drug
    Intervention Name(s)
    nano-luteolin
    Other Intervention Name(s)
    nanoluteolin
    Intervention Description
    nanoparticles of luteolin
    Primary Outcome Measure Information:
    Title
    gene expression of Caspase 3 to detect apoptosis
    Description
    fold-changes
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    cell viability
    Description
    micromolar
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC). Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term). Application of luteolin as a chemotherapeutic drug. Exclusion Criteria: Any cancer cell line other than OSCC, TSCC and HNSCC cell lines. Luteolin glycosides.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Safaa M. Baz, Masters
    Phone
    002 01119777824
    Email
    drsafaaelbaz@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Safa F. Abd El-Ghani, PhD
    Phone
    002 01005198010
    Email
    drsafa.fathy@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Elkhadem, PhD
    Organizational Affiliation
    Center for Evidence Based Dentistry
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24287949
    Citation
    Ding S, Hu A, Hu Y, Ma J, Weng P, Dai J. Anti-hepatoma cells function of luteolin through inducing apoptosis and cell cycle arrest. Tumour Biol. 2014 Apr;35(4):3053-60. doi: 10.1007/s13277-013-1396-5. Epub 2013 Nov 28.
    Results Reference
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    Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

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