Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Berberine Chloride; Laboratory Biomarker Analysis; Placebo Administration
Intervention description: Given PO; Correlative studies; Given PO
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3
             months, regardless of how long ago they were diagnosed for UC

          -  Receiving maintenance therapy with mesalamine for at least 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  Leukocytes >= 3,000/microliter

          -  Absolute neutrophil count >= 1,500/microliter

          -  Platelets >= 100,000/microliter

          -  Total bilirubin within normal institutional limits; higher values (=< 3 x
             institutional upper limit of normal [ULN]) are acceptable in participants with: 1.
             known or suspected cholangitis associated with Crohn's disease, or 2, known or
             suspected inborn errors of metabolism that lead to increased bilirubin

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOP])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 x institutional ULN

          -  Creatinine within normal institutional limits

          -  Women of child-bearing 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:

          -  Participants who have had any immunomodulatory treatment in the past 3 months will be
             excluded

          -  Participants who have taken any medicines that are inducers, inhibitors or substrates
             of select cytochrome (CYP) isozymes within the past 3 months will be excluded;
             participants who have consumed either grapefruit juice or Seville orange juice in the
             past 7 days will be excluded

          -  Participants with dysplasia-associated mass or lesion (DALM) due to longstanding
             idiopathic inflammatory bowel disease will be excluded

          -  Participants who are currently receiving any other investigational agents or have
             received investigational agents within the past 3 months will be excluded

          -  Participants with a history of allergic reactions attributed to compounds of similar
             chemical or biologic composition to berberine will be excluded

          -  Patients with uncontrolled intercurrent 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 in the opinion of
             investigators would jeopardize patient safety of data integrity are excluded;
             individuals who are human immunodeficiency virus (HIV) positive will not necessarily
             be excluded, will be considered on a case-by-case basis, but will be required to meet
             criteria related to patient safety and data integrity, as assessed by investigators

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with berberine; women are considered to be of child-bearing
             potential if they are not surgically sterile or under the age 65 and have menstruated
             within the last two years