Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line

Oral Cancer Clinical Trial

Official title:

Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05456022
• Other study ID #: 172022
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Hana'a Algadi, P.h.D
• Phone: 01116360252
• Email: hanaahezamalgadi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Oral Cancer

Intervention

Drug:
• Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one
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)
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 control
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

Locations

Country	Name	City	State
Egypt	11 Saraya El Manial	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 1 week after cell line propagation
Primary	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 ?ow cytometer apparatus	within 1 week after cell line propagation
Secondary	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.	within 1 week after cell line propagation
Secondary	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	within 1 week after cell line propagation
Secondary	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)	within 1 week after cell line propagation