Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Curcumin

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