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

NCT ID: NCT01790204

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-04-30

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.

Conditions

Oral Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Watercress Juice

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fung-Lung Chung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Locations

Georgetown Clinical Research Unit

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

R01CA1000853

Identifier Type: -

Identifier Source: org_study_id