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出境医 / 临床实验 / Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line

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

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.


Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Dietary Supplement: coffee Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: oral squamous cell carcinoma cell lines
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 17, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: no coffee
oral squamous cell carcinoma cell line without intervention
Dietary Supplement: coffee
coffee beverage

Active Comparator: green coffee
oral squamous cell carcinoma cell line with application of green coffee
Dietary Supplement: coffee
coffee beverage

Active Comparator: roasted coffee
oral squamous cell carcinoma cell line with application of roasted coffee
Dietary Supplement: coffee
coffee beverage

Active Comparator: decaffeinated coffee
oral squamous cell carcinoma cell line with application of decaffeinated coffee
Dietary Supplement: coffee
coffee beverage

Outcome Measures
Primary Outcome Measures :
  1. Apoptotic cell death [ Time Frame: 3 months ]
    Apoptosis


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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Asmaa E Mohammed, Master 02/01014287972 asmaa.rashad@dentistry.cu.edu.eg
Contact: Asmaa E Mohammed, Master 01067033924 asmaa201220120@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Manar M Abd el wanis Cairo University
Tracking Information
First Submitted Date  ICMJE July 6, 2018
First Posted Date  ICMJE August 7, 2018
Last Update Posted Date January 30, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
Apoptotic cell death [ Time Frame: 3 months ]
Apoptosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
Official Title  ICMJE Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
oral squamous cell carcinoma cell lines
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oral Squamous Cell Carcinoma
Intervention  ICMJE Dietary Supplement: coffee
coffee beverage
Study Arms  ICMJE
  • Experimental: no coffee
    oral squamous cell carcinoma cell line without intervention
    Intervention: Dietary Supplement: coffee
  • Active Comparator: green coffee
    oral squamous cell carcinoma cell line with application of green coffee
    Intervention: Dietary Supplement: coffee
  • Active Comparator: roasted coffee
    oral squamous cell carcinoma cell line with application of roasted coffee
    Intervention: Dietary Supplement: coffee
  • Active Comparator: decaffeinated coffee
    oral squamous cell carcinoma cell line with application of decaffeinated coffee
    Intervention: Dietary Supplement: coffee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 17, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03619304
Other Study ID Numbers  ICMJE CEBD-CU-2018-7-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asmaa Emad El- Din Mohammed, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manar M Abd el wanis Cairo University
PRS Account Cairo University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP