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

NCT05456022 | Unknown Phase 2 DMC

• 1 other identifier: 172022
• Study Type: interventional
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Cancer

Keywords

Tongue; SCC; chemotherapy; Quercetin; PLGA-PEG nanoparticle

Outcome Measures

Primary Outcomes (2)

• 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

• 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

  within 1 week after cell line propagation

Secondary Outcomes (3)

• Gene expression of (BCL-2) .

  within 1 week after cell line propagation

• Gene expression of ( Bax gene)

  within 1 week after cell line propagation

• survival pathway (Expression of pi3k gene)

  within 1 week after cell line propagation

Study Arms (3)

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

Interventions

Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one DRUG

Appearance (Color) Conforms Yellow Appearance (Form) Powder 1H NMR Spectrum Conforms to Structure Loss on Drying \< 4 % \_ Purity (HPLC) \> 95 %

Also known as: Citrus bioflavonoid, Sophoretin; Meletin; Quercetine; Xanthaurine; Quercetol; Quercitin; Quertine; Flavin

Quercetin drug.

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

Quercetin-encapsulated PLGA-PEG nanoparticles

Doxorubicin chemotherapeutic drug as a positive control DRUG

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

Doxorubicin chemotherapeutic drug

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

11 Saraya El Manial

Cairo, Egypt

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Flavonoids; Quercetin; 4,6-dinitro-o-cresol

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavonols

Central Study Contacts

Hana'a Algadi, P.h.D

CONTACT

01116360252; hanaahezamalgadi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. candidate at Oral &Maxillofacial Pathology Department- Faculty of Dentistry

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

EG (1)