Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)
Condition: Healthy, no Evidence of Disease; Tobacco Use Disorder
MeSH terms: Aberrant Crypt Foci; Tobacco Use Disorder
Intervention: laboratory biomarker analysis; pharmacological study; curcumin
Intervention description: Correlative studies; Correlative studies; Given orally
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Chemoprevention is the use of certain substances to keep cancer from forming, growing, or
      coming back. Curcumin is a compound found in plants that may prevent colon cancer from
      forming. This phase II trial is studying how well curcumin works in preventing colon cancer
      in smokers with aberrant crypt foci.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current smoker with > 3 pack-year total smoking history

          -  Subjects taking NSAIDS or ASA < 10 days month are eligible but must undergo 14 day
             washout and refrain from use during the study

          -  Subjects who are:

               -  Having a clinically indicated screening/surveillance colonoscopy (e.g. due to
                  risk factors, personal history, or symptoms) OR

               -  Not having a colonoscopy but are otherwise eligible. These subjects would undergo
                  a flexible sigmoidoscopy.

          -  ECOG performance status 0-2 (Karnofsky > 60%)

          -  No severe organ dysfunction which might increase bleeding risk:

               -  Demonstrated by: Normal hematologic status (WBC > 3,000/mm^3, hemoglobin > 10.0
                  gm/dl, and platelet-count >100,000/mm^3), normal hepatic function (bilirubin <
                  1.5 mg/dl, transaminases < 1.5x institutional norms), and normal renal function
                  (serum creatinine < 2.0 mg/dl, documented in clinical chart 28 days prior to
                  enrollment

          -  Healthy current smokers (1 cigarette in previous yr) with > 3-pack year of cigarette
             smoking and able to provide written informed consent; there are no gender restrictions

          -  The effects of curcumin on the developing human fetus at the recommended therapeutic
             dose are unknown; for this reason women of childbearing potential and men must agree
             to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation; should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her study physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  NSAID or ASA use > 10 days /month; any current glucocorticoid use or omega 3-fatty
             acid supplement use

          -  Evidence of the following chronic medical conditions such as:

               -  Pregnant or lactating women and/or women who are contemplating pregnancy during
                  the duration of the protocol

               -  History of chronic inflammatory bowel disease or prior pelvic irradiation

               -  History of peptic ulcer disease (PUD) endoscopically confirmed < 5 yrs from
                  enrollment date

               -  Newly diagnosed colorectal cancer or advanced adenoma < 1 yr from enrollment

               -  Unspecified history of bleeding or coagulation disorder reported by patient or in
                  medical history

               -  Hereditary Colon Cancer syndromes (FAP or HNPCC)

          -  Participants may not be receiving any other investigational agents

          -  History of contact dermatitis from turmeric

          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because curcumin is an agent with the
             potential for teratogenic or abortifacient effects; because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with curcumin, breastfeeding should be discontinued if the mother is treated
             with curcumin