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

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Brief Title

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


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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.


Condition

Oral Cancer

Intervention

Watercress Juice

Study Arms / Comparison Groups

 Watercress Juice
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

55

Start Date

February 2012

Completion Date

April 2014

Primary Completion Date

April 2014

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
      

Gender

All

Ages

20 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Fung-Lung Chung, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01790204

Organization ID

R01CA1000853


Responsible Party

Sponsor

Study Sponsor

Georgetown University


Study Sponsor

Fung-Lung Chung, Ph.D., Principal Investigator, Lombardi Comprehensive Cancer Center


Verification Date

November 2013