A Study of the Effects of PEITC on Oral Cells With Mutant p53
Completed · Phase 1/Phase 2
Conditions studied: Oral Cancer
In brief
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.
Key facts
- Study ID
- NCT01790204
- Run by
- Georgetown University
- People needed
- 55
- Starts
- 2012-02-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-03-23
Who can join
Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Georgetown Clinical Research Unit — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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