NCT03619304

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

July 6, 2018

Last Update Submit

January 29, 2019

Conditions

Oral Squamous Cell Carcinoma

Keywords

coffee, oral squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Apoptotic cell death

    Apoptosis

    3 months

Study Arms (4)

no coffee

EXPERIMENTAL

oral squamous cell carcinoma cell line without intervention

Dietary Supplement: coffee

green coffee

ACTIVE COMPARATOR

oral squamous cell carcinoma cell line with application of green coffee

Dietary Supplement: coffee

roasted coffee

ACTIVE COMPARATOR

oral squamous cell carcinoma cell line with application of roasted coffee

Dietary Supplement: coffee

decaffeinated coffee

ACTIVE COMPARATOR

oral squamous cell carcinoma cell line with application of decaffeinated coffee

Dietary Supplement: coffee

Interventions

coffeeDIETARY_SUPPLEMENT

coffee beverage

decaffeinated coffeegreen coffeeno coffeeroasted coffee

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- mixed tumors animal cell lines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Coffee

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Manar M Abd el wanis

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa E Mohammed, Master

CONTACT

02/01014287972asmaa.rashad@dentistry.cu.edu.eg

Asmaa E Mohammed, Master

CONTACT

01067033924asmaa201220120@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: oral squamous cell carcinoma cell lines
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant oral pathology department

Study Record Dates

First Submitted

July 6, 2018

First Posted

August 7, 2018

Study Start

September 1, 2019

Primary Completion

December 30, 2019

Study Completion

July 17, 2020

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share