NCT03288298

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

September 12, 2017

Last Update Submit

September 18, 2017

Conditions

Keywords

TSCCOSCCluteolinnanoluteolinnanotechnologyoral cancerapoptosisPCRMTTELISA reader

Outcome Measures

Primary Outcomes (1)

  • gene expression of Caspase 3 to detect apoptosis

    fold-changes

    6 hours

Secondary Outcomes (1)

  • cell viability

    6 hours

Study Arms (2)

luteolin

EXPERIMENTAL

a natural extract derived flavinoids

Drug: luteolin

nano-luteolin

ACTIVE COMPARATOR

nano-particles derived from a natural extract luteolin

Drug: nano-luteolin

Interventions

flavonoid natural extract

Also known as: 3',4',5,7-tetrahydroxyflavone
luteolin

nanoparticles of luteolin

Also known as: nanoluteolin
nano-luteolin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 24287949BACKGROUND

MeSH Terms

Conditions

Tongue NeoplasmsCarcinomaMouth Neoplasms

Interventions

Luteolin

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed Elkhadem, PhD

    Center for Evidence Based Dentistry

    STUDY CHAIR

Central Study Contacts

Safaa M. Baz, Masters

CONTACT

Safa F. Abd El-Ghani, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer, Oral and Maxillofacial Pathology, BUE

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 20, 2017

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

April 1, 2019

Last Updated

September 20, 2017

Record last verified: 2017-09