Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

NCT ID: NCT03333265

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-06-01

Brief 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.

Detailed Description

Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer.

BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis.

Conditions

Colorectal Adenomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

100mg Berberine hydrochloride group

Berberine hydrochloride 100mg tablet by mouth, two times per day for 6 months

Group Type: EXPERIMENTAL

100mg Berberine hydrochloride

Intervention Type: DRUG

patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months

300mg Berberine hydrochloride group

Berberine hydrochloride 300mg tablet by mouth, two times per day for 6 months

Group Type: EXPERIMENTAL

300mg Berberine hydrochloride

Intervention Type: DRUG

patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months

Placebo oral tablets

identical-appearing placebo tablets by mouth, two times per day for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Interventions

100mg Berberine hydrochloride

patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months

Intervention Type: DRUG

300mg Berberine hydrochloride

patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months

Intervention Type: DRUG

Placebo Oral Tablet

patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Intervention Type: DRUG

Other Intervention Names

100mg Berberine hydrochloride tablet ("Sine Tianping"); 300mg Berberine hydrochloride tablet ("Sine Tianping"); Placebo (for Berberine hydrochloride)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

xiaohua li

Director of colorectal surgery center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weizhong Wang, MD,PH.D

Role: PRINCIPAL_INVESTIGATOR

Xijing digestive surgery center

Locations

Li

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XJLL 2016 017

Identifier Type: -

Identifier Source: org_study_id