Tongue NeoplasmsEarly Phase 1NCT03288298
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line
A Early Phase 1 study testing luteolin and nano-luteolin in people with Tongue Neoplasms and Carcinoma, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tongue Neoplasms, Carcinoma
- What is being tested?
- luteolin and nano-luteolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Apr 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
- Luteolin glycosides.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study
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.
Read the 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.
- Conditions
- Tongue Neoplasms, Carcinoma
- Being tested
- luteolin, nano-luteolin
- Keywords
- TSCC, OSCC, luteolin, nanoluteolin, nanotechnology, oral cancer, apoptosis, PCR, MTT, ELISA reader
- Medical subject headings
- Tongue Neoplasms, Carcinoma, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteolinDrug
Also called 3',4',5,7-tetrahydroxyflavone
flavonoid natural extract
nano-luteolinDrug
Also called nanoluteolin
nanoparticles of luteolin
| Study group | Role | What they receive |
|---|---|---|
| luteolin | Experimental | a natural extract derived flavinoids Receives: Drug: luteolin |
| nano-luteolin | Active comparator | nano-particles derived from a natural extract luteolin Receives: Drug: nano-luteolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression of Caspase 3 to detect apoptosis
fold-changes
Measured: 6 hours
Secondary outcomes (1)
cell viability
micromolar
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tongue NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Elbaz, Cairo University
- Investigators
- Ahmed Elkhadem, PhD, Study chair, Center for Evidence Based Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288298
- Sponsor's protocol ID
- CEBD-CU-2017-09-23
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24287949
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study
- ClinicalTrials.gov ID
- NCT03288298
- Acronym / sponsor ID
- CEBD-CU-2017-09-23
- Conditions
- Tongue Neoplasms, Carcinoma
- Keywords
- TSCC, OSCC, luteolin, nanoluteolin, nanotechnology, oral cancer, apoptosis, PCR
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| luteolin | Experimental | Drug: luteolina natural extract derived flavinoids |
| nano-luteolin | Active comparator | Drug: nano-luteolinnano-particles derived from a natural extract luteolin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
- Luteolin glycosides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| luteolinAlso: 3',4',5,7-tetrahydroxyflavoneflavonoid natural extract | Drug | luteolin |
| nano-luteolinAlso: nanoluteolinnanoparticles of luteolin | Drug | nano-luteolin |
Primary outcome
gene expression of Caspase 3 to detect apoptosis
Time frame: 6 hours
fold-changes
1 secondary outcome
cell viability
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Background: PubMed 24287949Ding 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elkhadem, PhD study chair
Center for Evidence Based Dentistry
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing luteolin and nano-luteolin in people with Tongue Neoplasms and Carcinoma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa M. Baz, Masters (002 01119777824, drsafaaelbaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression of Caspase 3 to detect apoptosis (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.