Clinical trial NCT01790204: A Study of the Effects of PEITC on Oral Cells With Mutant p53
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Oral Cancer
Keywords: mutant p53
watercress
Phenethyl isothyocyanate
oral cells of smokers
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Clinical Research Unit
state: District of Columbia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Fung-Lung Chung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: