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

NCT03288298 — Early Phase 1, Unknown, 4 participants, Cairo University

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Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study

Registry	NCT03288298
Status	Unknown
Phase	Early Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	4 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Tongue Neoplasms, Carcinoma
Interventions	luteolin, nano-luteolin (Drug)
Dates	start 2017-11-01 (estimated), primary completion 2018-09-01 (estimated), completion 2019-04-01 (estimated), first posted 2017-09-20, last updated 2017-09-20

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
luteolin	Experimental	Drug: luteolin	a natural extract derived flavinoids
nano-luteolin	Active comparator	Drug: nano-luteolin	nano-particles derived from a natural extract luteolin

luteolin (Drug), also known as 3',4',5,7-tetrahydroxyflavone: flavonoid natural extract
nano-luteolin (Drug), also known as nanoluteolin: nanoparticles of luteolin

+Outcome measures

Primary outcomes

gene expression of Caspase 3 to detect apoptosis [6 hours]: fold-changes

Secondary outcomes

cell viability [6 hours]: micromolar

+Eligibility

Sex: All

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.

+Publications

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. PMID 24287949

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2017-09-18)

+Investigators

Ahmed Elkhadem, PhD, Study chair, Center for Evidence Based Dentistry

My Notes

Public

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