Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: xiaohua li

Criteria

Inclusion Criteria:

• Patients aged 18-65 years

• Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically

• All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations.

• Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery

Exclusion Criteria:

• Patients who are hypersensitive or intolerant to the drugs

• Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization

• Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter))

• Patients with diabetes mellitus, severe renal disease or cardiovascular disease (defined by a New York Heart Association functional classof III or IV)

• Patients with hypercalcemia or urolithiasis

• Patients with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency

• Patients had clinically obvious narcotic or alcohol dependence during the previous 6 months

• Patients had used NSAIDs including aspirin at any dose on 3 or more days per month during each of the 3 months before enrollment or for a period of 36 days in the previous year; or had a history of stroke, transient ischemic attacks, angina, myocardial infarction, or atherosclerotic peripheral vascular disease

• Pregnant women, women during breast-feeding period, or women with expect pregnancy

• Patients with a history of subtotal gastrectomy or partial bowel resection

• Patients who are not able to cooperate

• Individual who are involved in designing, planning or performing this clinical trial

• Patients with medical conditions who are not appropriate to participate the study

• Patients with any condition that could be worsened by supplemental Berberine hydrochloride