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
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
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
NCT ID
NCT03288298
First Posted
September 12, 2017
Last Updated
September 18, 2017
Sponsor
Cairo University
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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