Oral CancerPhase 2NCT05456022
Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line
A Phase 2 study testing Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one and Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT) in people with Oral Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations.The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one and Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000,000 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2022to Dec 2023
- Phase
- Phase 2
- 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
- Tongue Squamous cell carcinoma cell lines
- Quercetin drug.
- Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)
- Application of a Quercetin drug as chemotherapeutic drug.
- Detection of Quercetin activity in apoptosis or cytotoxicity/cell viability.
Who cannot join
- Any cancer cell line other than tongue Squamous cell carcinoma cell lines
- Any use of Quercetin other than chemotherapy.
- Detection of Quercetin activities other than apoptosis or cytotoxicity/cell viability
Trial locations and contacts
1 site in 1 country.
About this study
Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations.The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells.Quercetin is a bioactive flavonoid having strong antioxidant properties. .Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers.This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.
Read the detailed description
Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations. The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells. Quercetin is a bioactive flavonoid having strong antioxidant properties. It is naturally present in a wide variety of fruits and vegetables. Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers. Polymeric nanocarriers have been fabricated from natural and synthetic polymers. Poly ethylene glycol-poly lactide-co-glycolic acid (PEG-PLGA) amphiphilic copolymer is an emergent system because it can be easily synthesized and possesses a lot of good qualities. Several previous in vitro and in vivo studies have evaluated the cytotoxic effects of quercetin and have revealed that it decreases cell viability and increases cell apoptotic rate in OSCC. However, the anti-cancer property of quercetin in tongue squamous cell carcinoma (TSCC) has not been studied yet. This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.
- Conditions
- Oral Cancer
- Being tested
- Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one, Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT), Doxorubicin chemotherapeutic drug as a positive control
- Keywords
- Tongue, SCC, chemotherapy, Quercetin, PLGA-PEG nanoparticle
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-oneDrug
Also called Citrus bioflavonoid, Sophoretin; Meletin; Quercetine; Xanthaurine; Quercetol; Quercitin; Quertine; Flavin
Appearance (Color) Conforms Yellow Appearance (Form) Powder
1H NMR Spectrum Conforms to Structure Loss on Drying < 4 % _ Purity (HPLC) > 95 %
Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)Drug
Nano QUT will prepared by PLGA-PEG nanocomposites that will be prepared by an oil-in-water (O/W) single emulsion solvent evaporation method
Doxorubicin chemotherapeutic drug as a positive controlDrug
Doxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2
| Study group | Role | What they receive |
|---|---|---|
| Quercetin drug. | Experimental | Not described Receives: Drug: Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one |
| Quercetin-encapsulated PLGA-PEG nanoparticles | Experimental | Not described Receives: Drug: Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT) |
| Doxorubicin chemotherapeutic drug | Active comparator | Not described Receives: Drug: Doxorubicin chemotherapeutic drug as a positive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytotoxicity/Cell viability.
MTT assay for cellular viability:
The cytotoxic impacts of the tested drugs and Nano QUT-encapsulation will be measured by MTT. The (HNO-97) cells will be cultured in 96-well plates at a density of 5 × 103 cells/well. All drugs with their described concentrations will be added to the media over tongue SCC cell lines. After a day of incubation, the dissolved MTT in PBS will be added to each well at a final concentration of 5 mg/ml, and the samples will be incubated at 37 °C for 4h. Water-insoluble dark blue formazan crystals that will be formed during MTT cleavage in actively metabolizing cells will then be dissolved in dimethyl sulfoxide (DMSO). Absorbance will be measured at A455 nm, using an ELISA microplate reader
Measured: within 1 week after cell line propagation
Apoptosis.
Annexin V and propidium iodide (PI) stains will be used in the determination of apoptosis after treatment with the free, nano counterpart of QUT and free Dox post 24h of their incubation over the HNO-97 cell line. The apoptotic analysis will be dedicated to differentiating between early and late apoptotic cells, as well as necrotic cells. The apoptosis of the treated and untreated HNO-97 line with the proposed free, nano counterpart of Nano-QUT and Dox will be analyzed by flow cytometer apparatus
Measured: within 1 week after cell line propagation
Secondary outcomes (3)
Gene expression of (BCL-2) .
Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of the apoptotic signals (BCL-2 and Bax) and survival pathway (Expression of PI3K gene). GAPDH will be used as a housekeeping gene to normalize the level of target gene expression.
Measured: within 1 week after cell line propagation
Gene expression of ( Bax gene)
Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of the apoptotic Bax gene
Measured: within 1 week after cell line propagation
survival pathway (Expression of pi3k gene)
Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of survival pathway (Expression of pi3k gene)
Measured: within 1 week after cell line propagation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hana'a Hezam Ghaleb Algadi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456022
- Sponsor's protocol ID
- 172022
- Status last verified
- Jul 2022
- First submitted
- 25 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line
- ClinicalTrials.gov ID
- NCT05456022
- Acronym / sponsor ID
- 172022
- Conditions
- Oral Cancer
- Keywords
- Tongue, SCC, chemotherapy, Quercetin, PLGA-PEG nanoparticle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jul 2022 (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.
Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations.The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells.Quercetin is a bioactive flavonoid having strong antioxidant properties. .Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers.This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.
Detailed description
Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations. The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells. Quercetin is a bioactive flavonoid having strong antioxidant properties. It is naturally present in a wide variety of fruits and vegetables. Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers. Polymeric nanocarriers have been fabricated from natural and synthetic polymers. Poly ethylene glycol-poly lactide-co-glycolic acid (PEG-PLGA) amphiphilic copolymer is an emergent system because it can be easily synthesized and possesses a lot of good qualities. Several previous in vitro and in vivo studies have evaluated the cytotoxic effects of quercetin and have revealed that it decreases cell viability and increases cell apoptotic rate in OSCC. However, the anti-cancer property of quercetin in tongue squamous cell carcinoma (TSCC) has not been studied yet. This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quercetin drug. | Experimental | Drug: Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one |
| Quercetin-encapsulated PLGA-PEG nanoparticles | Experimental | Drug: Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT) |
| Doxorubicin chemotherapeutic drug | Active comparator | Drug: Doxorubicin chemotherapeutic drug as a positive control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Tongue Squamous cell carcinoma cell lines
- Quercetin drug.
- Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)
- Application of a Quercetin drug as chemotherapeutic drug.
- Detection of Quercetin activity in apoptosis or cytotoxicity/cell viability.
Key exclusion criteria (3 listed)
- Any cancer cell line other than tongue Squamous cell carcinoma cell lines
- Any use of Quercetin other than chemotherapy.
- Detection of Quercetin activities other than apoptosis or cytotoxicity/cell viability
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 |
|---|---|---|
| Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-oneAlso: Citrus bioflavonoid, Sophoretin; Meletin; Quercetine; Xanthaurine; Quercetol; Quercitin; Quertine; FlavinAppearance (Color) Conforms Yellow Appearance (Form) Powder 1H NMR Spectrum Conforms to Structure Loss on Drying < 4 % _ Purity (HPLC) > 95 % | Drug | Quercetin drug. |
| Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)Nano QUT will prepared by PLGA-PEG nanocomposites that will be prepared by an oil-in-water (O/W) single emulsion solvent evaporation method | Drug | Quercetin-encapsulated PLGA-PEG nanoparticles |
| Doxorubicin chemotherapeutic drug as a positive controlDoxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2 | Drug | Doxorubicin chemotherapeutic drug |
Primary outcome
Cytotoxicity/Cell viability.
Time frame: within 1 week after cell line propagation
MTT assay for cellular viability: The cytotoxic impacts of the tested drugs and Nano QUT-encapsulation will be measured by MTT. The (HNO-97) cells will be cultured in 96-well plates at a density of 5 × 103 cells/well. All drugs with their described concentrations will be added to the media over tongue SCC cell lines. After a day of incubation, the dissolved MTT in PBS will be added to each well at a final concentration of 5 mg/ml, and the samples will be incubated at 37 °C for 4h. Water-insoluble dark blue formazan crystals that will be formed during MTT cleavage in actively metabolizing cells will then be dissolved in dimethyl sulfoxide (DMSO). Absorbance will be measured at A455 nm, using an ELISA microplate reader
Apoptosis.
Time frame: within 1 week after cell line propagation
Annexin V and propidium iodide (PI) stains will be used in the determination of apoptosis after treatment with the free, nano counterpart of QUT and free Dox post 24h of their incubation over the HNO-97 cell line. The apoptotic analysis will be dedicated to differentiating between early and late apoptotic cells, as well as necrotic cells. The apoptosis of the treated and untreated HNO-97 line with the proposed free, nano counterpart of Nano-QUT and Dox will be analyzed by flow cytometer apparatus
3 secondary outcomes
Gene expression of (BCL-2) .
Time frame: within 1 week after cell line propagation
Gene expression of ( Bax gene)
Time frame: within 1 week after cell line propagation
survival pathway (Expression of pi3k gene)
Time frame: within 1 week after cell line propagation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one and Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT) in people with Oral Cancer, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 3 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hana'a Algadi, P.h.D (01116360252, hanaahezamalgadi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytotoxicity/Cell viability. (time frame: within 1 week after cell line propagation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.