Back to resultsA Study of the Effects of PEITC on Oral Cells With Mutant p53
Primary Purpose
Oral Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Watercress Juice
Sponsored by
About this trial
This is an interventional prevention trial for Oral Cancer focused on measuring mutant p53, watercress, Phenethyl isothyocyanate, oral cells of smokers
Eligibility Criteria
Inclusion Criteria:
- Heavy Smoker
- Between the ages of 20 and 65
- Must be able to show proof of citizenship or residency of the United States
- Able to sign and understand a standard consent form
Exclusion Criteria:
- Pregnant or Breast-feeding
- Having any of the following medical conditions:
- Leukoplakia
- Oral Lesions
- Cancer
- Any oral disease that causes sores, ulcerations, irritations, etc.
- Stomach or Intestinal Ulcers
- IBS (Irritable Bowel Syndrome)
- Kidney Disease
- Allergies to watercress or other Cruciferous Vegetables
- Strict Vegetarians or Vegans
- Religious Consumers of Watercress or other Cruciferous Vegetable Juices
- On any of the following medications:
- Chlorzoxazone (Parafon Forte, Paraflex)
- Lithium
- Water Pills/Diuretics (Thiazide or Lasix)
- Warfarin (Coumadin)
- Vitamin K supplements
- H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
- Proton Pump Inhibitor (Prevacid)
- Digoxin
- Antibiotics
- Diabetic Medications (Insulin)
- Inhaled Bronchodilator
- Oral Steroids (Prednisone, Medrol)
- Inhaled Steroids (Flonase)
- Raloxifene or Tamoxifen
- Thyroid Hormone Replacement
Sites / Locations
- Georgetown Clinical Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Watercress Juice
Arm Description
The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Outcomes
Primary Outcome Measures
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
Secondary Outcome Measures
Full Information
NCT ID
NCT01790204
First Posted
February 11, 2013
Last Updated
March 19, 2015
Sponsor
Georgetown University
1. Study Identification
Unique Protocol Identification Number
NCT01790204
Brief Title
A Study of the Effects of PEITC on Oral Cells With Mutant p53
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral cells will contain measurable levels of mutant p53. The participants will consume watercress juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral cells. This depletion could lead to a possible clinical application of this compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
mutant p53, watercress, Phenethyl isothyocyanate, oral cells of smokers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Watercress Juice
Arm Type
Experimental
Arm Description
The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Intervention Type
Dietary Supplement
Intervention Name(s)
Watercress Juice
Intervention Description
The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Primary Outcome Measure Information:
Title
Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heavy Smoker
Between the ages of 20 and 65
Must be able to show proof of citizenship or residency of the United States
Able to sign and understand a standard consent form
Exclusion Criteria:
Pregnant or Breast-feeding
Having any of the following medical conditions:
Leukoplakia
Oral Lesions
Cancer
Any oral disease that causes sores, ulcerations, irritations, etc.
Stomach or Intestinal Ulcers
IBS (Irritable Bowel Syndrome)
Kidney Disease
Allergies to watercress or other Cruciferous Vegetables
Strict Vegetarians or Vegans
Religious Consumers of Watercress or other Cruciferous Vegetable Juices
On any of the following medications:
Chlorzoxazone (Parafon Forte, Paraflex)
Lithium
Water Pills/Diuretics (Thiazide or Lasix)
Warfarin (Coumadin)
Vitamin K supplements
H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
Proton Pump Inhibitor (Prevacid)
Digoxin
Antibiotics
Diabetic Medications (Insulin)
Inhaled Bronchodilator
Oral Steroids (Prednisone, Medrol)
Inhaled Steroids (Flonase)
Raloxifene or Tamoxifen
Thyroid Hormone Replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fung-Lung Chung, Ph.D.
Organizational Affiliation
Lombardi Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown Clinical Research Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effects of PEITC on Oral Cells With Mutant p53
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