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

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ClinicalTrials.gov Identifier: NCT05456022
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Hana'a Hezam Ghaleb Algadi, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one Drug: Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT) Drug: Doxorubicin chemotherapeutic drug as a positive control Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000000 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Quercetin drug. 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 %

Other Name: Citrus bioflavonoid, Sophoretin; Meletin; Quercetine; Xanthaurine; Quercetol; Quercitin; Quertine; Flavin
Experimental: Quercetin-encapsulated PLGA-PEG nanoparticles 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
Active Comparator: Doxorubicin chemotherapeutic drug Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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


Secondary Outcome Measures :
  1. Gene expression of (BCL-2) . [ Time Frame: within 1 week after cell line propagation ]
    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.

  2. Gene expression of ( Bax gene) [ Time Frame: within 1 week after cell line propagation ]
    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

  3. survival pathway (Expression of pi3k gene) [ Time Frame: within 1 week after cell line propagation ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05456022


Contacts
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Contact: Hana'a Algadi, P.h.D 01116360252 hanaahezamalgadi@yahoo.com

Locations
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Egypt
11 Saraya El Manial
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Hana'a Hezam Ghaleb Algadi, Ph.D. candidate at Oral &Maxillofacial Pathology Department- Faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier: NCT05456022    
Other Study ID Numbers: 172022
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hana'a Hezam Ghaleb Algadi, Cairo University:
Tongue
SCC
chemotherapy
Quercetin
PLGA-PEG nanoparticle
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Mouth Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
 Doxorubicin
Quercetin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs