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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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ClinicalTrials.gov Identifier: NCT03619304
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Emad El- Din Mohammed, Cairo University

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.


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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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


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): NCT03619304


Contacts
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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
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Principal Investigator: Manar M Abd el wanis Cairo University
  Study Documents (Full-Text)

Documents provided by Asmaa Emad El- Din Mohammed, Cairo University:
Study Protocol  [PDF] June 30, 2018


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Responsible Party: Asmaa Emad El- Din Mohammed, Teaching assistant oral pathology department, Cairo University
ClinicalTrials.gov Identifier: NCT03619304     History of Changes
Other Study ID Numbers: CEBD-CU-2018-7-02
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Asmaa Emad El- Din Mohammed, Cairo University:
coffee, oral squamous cell carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell