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
About this trial
This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring coffee, oral squamous cell carcinoma
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
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
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
Learn more about this trial
Assessment of Anti-cancerous Effect of Green, Roasted and Decaffeinated Coffee on Oral Squamous Cell Carcinoma Cell Line
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