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Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line

Primary Purpose

Oral Squamous Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coffee
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring coffee, oral squamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • human cell lines
  • only oral squamous cell carcinoma cell line
  • green coffee extract
  • roasted coffee extract
  • decaffeinated coffee extract

Exclusion Criteria:

- mixed tumors animal cell lines

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    no coffee

    green coffee

    roasted coffee

    decaffeinated coffee

    Arm Description

    oral squamous cell carcinoma cell line without intervention

    oral squamous cell carcinoma cell line with application of green coffee

    oral squamous cell carcinoma cell line with application of roasted coffee

    oral squamous cell carcinoma cell line with application of decaffeinated coffee

    Outcomes

    Primary Outcome Measures

    Apoptotic cell death
    Apoptosis

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2018
    Last Updated
    January 29, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03619304
    Brief Title
    Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
    Official Title
    Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2019 (Anticipated)
    Study Completion Date
    July 17, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oral cancer is the sixth most common cancer worldwide. Over 90% of all identified oral cavity cancers are invasive oral squamous cell carcinomas (OSCCs). Primary treatments of OSCC are surgery, radiation therapy, and chemotherapy. However, anticancer therapies (drugs, irradiation) have undesirable side effects as they may induce mutations or irreversible DNA damage killing healthy cells. One of the most frequently used alternative therapies is herbal medicine that act as anti-ROS agents preventing DNA damage has been used alongside conventional treatment regimens. One of the agents that receives particular strong interest is coffee. Coffee is considered as a major source of dietary antioxidants; some are present in the green bean, whereas others are generated during roasting. Coffee roasting, the process of the heating of green coffee beans transforming them into black coffee beans, transforms the chemical and biological properties of coffee beans. Regarding oral cancer, some studies reported an association of high coffee consumption to an augmented risk of oral cancer while others showed a clear inverse association with the risk of oral cancer. Recently, there have been reports of a protective effect of coffee consumption on oral cancer from two recent meta-analysis. To our knowledge, only two studies were done to assess the effect of coffee ingredients (cafestol and kahweol) on oral squamous cell carcinoma cell lines. Due to these controversial findings concerning the effect of roasted coffee and absence of data on unprocessed (green coffee), our study aims to investigate the effect of different coffee beverage as regard apoptosis and proliferation carried out in OSCC cell lines.
    Detailed Description
    Oral cancer is the sixth most common cancer in males and the twelfth most common in females. Approximately, 94% of all oral malignancies are squamous cell carcinoma. Over the past few decades, researchers have explored alternate therapies and remedies to prevent its progression but have yielded to low success rates. Targeted therapy of oral cancer is promising following identification of anticancer biomolecules. Naturally available extracts have been desired after in this regard as an adjunctive therapeutic modality. Current research in the head and neck cancer mainly focuses to understand the molecular mechanisms of oral cancer development and progression to target the biomarkers and facilitate the development of new treatment strategies. Studies with cell lines can serve as an initial screen for agents that might regulate drug resistance and to establish whether the differences exist in the different drug-resistant sublines. Phytochemicals and extracts derived from medicinal plants have been noted as promising cancer-preventive agents against several cancers because of their low toxicity and the accumulating data supporting their beneficial health effects. Coffee, after water, is the leading beverage in the world which highlights the importance of knowledge of its possible influence on human health. Coffee beverages contain a variety of antioxidant and antimutagen agents including phenolic derivatives such as chlorogenic acid and polyphenol caffeic acid and diterpenes such as cafestol and kahweol. Some studies have suggested that these constituents could provide some genotoxicity protection thus classifying coffee as anti-cancer agent. However, future work in the mechanism is needed because coffee has many components, and effects may depend on multiple factors such as the type of coffee bean, caffeinated compared with decaffeinated coffee, roasting, and brewing methods. Several studies have tried to analyze the contribution of coffee consumption on the risk of different cancer types. The effect of coffee on cancer risk is controversial because both inhibiting and promoting effects have been suggested. The antioxidative effect of chlorogenic acid and the inhibitory effect of DNA methylation are considered to contribute to coffee's protective effect. A protective effect of coffee has been observed in humans for a variety of cancers. The most recent studies have reported that coffee is inversely associated with oral cancer/pharyngeal cancer, basal cell carcinoma and endometrial cancer type I. Coffee drinking has been also inversely related to colorectal cancer and liver cancer. However, the caffeine in coffee is known to modify the apoptotic response and disturb cell checkpoint integrity. The type of coffee has a significant impact on their antioxidant potential. Thermal treatment of coffee beans (roasting process) also affects the level of antioxidant potential. Roasting process transforms the chemical and biological properties of coffee beans and increases its antioxidant activity. Roasted coffee beans exhibited higher antioxidant capacity than green coffee beans, and intensified coffee roasting resulted in a decrease of its antioxidant potential. To our knowledge, only one study which reported the effect of different types of coffee beverage (caffeinated, decaffeinated and coffee) on oral cancer risk. Besides, the evidence of the effect of green coffee and decaffeinated coffee on OSCC was very scarce. The exact biological mechanism of potentially healthy role of coffee in head and neck cancer is still not available.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Squamous Cell Carcinoma
    Keywords
    coffee, oral squamous cell carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    oral squamous cell carcinoma cell lines
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    no coffee
    Arm Type
    Experimental
    Arm Description
    oral squamous cell carcinoma cell line without intervention
    Arm Title
    green coffee
    Arm Type
    Active Comparator
    Arm Description
    oral squamous cell carcinoma cell line with application of green coffee
    Arm Title
    roasted coffee
    Arm Type
    Active Comparator
    Arm Description
    oral squamous cell carcinoma cell line with application of roasted coffee
    Arm Title
    decaffeinated coffee
    Arm Type
    Active Comparator
    Arm Description
    oral squamous cell carcinoma cell line with application of decaffeinated coffee
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    coffee
    Intervention Description
    coffee beverage
    Primary Outcome Measure Information:
    Title
    Apoptotic cell death
    Description
    Apoptosis
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: human cell lines only oral squamous cell carcinoma cell line green coffee extract roasted coffee extract decaffeinated coffee extract Exclusion Criteria: - mixed tumors animal cell lines
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa E Mohammed, Master
    Phone
    02/01014287972
    Email
    asmaa.rashad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa E Mohammed, Master
    Phone
    01067033924
    Email
    asmaa201220120@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manar M Abd el wanis
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line

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