A Study of the Effects of PEITC on Oral Cells With Mutant p53

Oral Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790204
• Other study ID #: R01CA1000853
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 11, 2013
• Last updated: March 19, 2015
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Oral Cancer

Intervention

Dietary Supplement:
• Watercress Juice
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.

Locations

Country	Name	City	State
United States	Georgetown Clinical Research Unit	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.		8 hours	No