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Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission

Ulcerative Colitis Clinical Trial

Official title:
Phase I Trial of Berberine in Subjects With Ulcerative Colitis

Clinical Trial Summary

This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the safety of berberine (berberine chloride) administered to participants with ulcerative colitis (UC) in clinical remission while receiving maintenance therapy with mesalamine. SECONDARY OBJECTIVES: I. Determine the molecular efficacy of berberine by examining the following biomarkers: - Plasma-based measures of inflammation, including the blood C-reaction protein (CRP) level, erythrocyte sedimentation rate (ESR), and cytokines such as TNFa, IL-4, IL-6, IL-8 and IL-10 measured by enzyme-linked immunosorbent assay (ELISA). - Tissue-based measures of inflammation, including TNFα, COX-2, and NF-kappa (κ)B by immunohistochemistry (IHC), and anti-cancer action, including antigen Ki-67 (Ki67) and activated caspase-3 by IHC, and deoxyribonucleic acid (DNA) methylation on SFRP1, TCERG1L FBN2, TFPI2 using the methylation-specific polymerase chain reaction (qMSP) strategy. II. Clinical efficacy: UC related symptoms will be measured using the Ulcerative Colitis Disease Activity Index (i.e. the Mayo score) (UCDAI). III. Histological analysis for inflammation: severity of histologic inflammation will be evaluated using the Geboes grading system. IV. Determine plasma concentration of berberine. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive berberine chloride orally (PO) thrice daily (TID) for 90 days in the absence of disease progression or unacceptable toxicity. ARM II: Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are follow-up for 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02365480
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date June 16, 2016
Completion date December 13, 2019
View Details
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