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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active Over 18 Other 802193 NCT00118989

Trial Description

Summary

Specific Aims:

• To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.

Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.

• To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.

Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.

• To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps

Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.

• To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids

Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.

Eligibility Criteria

Inclusion Criteria:

• Age>18

• A diagnosis for colon/rectal polyp resection, polypectomy

• Subjects must be able to have the capacity and must be willing to provide informed consent

• Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study

• Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility

Exclusion Criteria:

• Previous or current history of colorectal cancer

• Previous history of Familial Polyposis Syndromes

• Previous history of inflammatory bowel disease

• Previous surgery of the large bowel

• Liver disease defined as AST and ALT>3x upper limit of normal

• Known history of gallstones, biliary colic or serum bilirubin >2.0

• Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia

• Renal disease defined as creatinine >1.5

• Hematopoietic disease defined as WBC<4000, platelet count <100,000, hemoglobin<10.0 or coagulation or bleeding disorder

• Significantly impaired gastrointestinal function or absorption

• Peptic ulcer disease

• Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV

• Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs

• Pregnant or lactating women

• Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol

• Inability to swallow pills

• Prior or concurrent therapy with any herbal or dietary supplement containing curcuminoids

• Concurrent use of anticoagulants or antiplatelets including warfarin, clopidogrel

• Prior or concurrent use of colorectal cancer chemopreventive agents including herbals: Sulindac or other NSAIDs, aspirin, COX-2 inhibitors, 5-aminosalicylate, folate, calcium, or their use within 14 days of enrollment

• Concurrent use of immunosuppressants

Trial Contact Information

Trial Lead Organizations/Sponsors

Abramson Cancer Center of the University of Pennsylvania

Carmen E Guerra, M.D.

Principal Investigator

Lisa Bowerman		Ph: (215) 573-4739
		Email: lisa.bowerman@uphs.upenn.edu

U.S.A.
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Lisa Bowerman	Ph: 215-573-4739
			Email: lisa.bowerman@uphs.upenn.edu
		Carmen E Guerra, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00118989
Information obtained from ClinicalTrials.gov on July 29, 2008