Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Colorectal Adenomas Clinical Trial

Official title:

The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333265
• Other study ID #: XJLL 2016 017
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2022
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyposis Coli
• Colorectal Adenomas

Intervention

Drug:
• 100mg Berberine hydrochloride
patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months
• 300mg Berberine hydrochloride
patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months
• Placebo Oral Tablet
patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Locations

Country	Name	City	State
China	Li	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis	The primary objective of this study is to investigate the number and diameters of colorectal polyps after Berberine hydrochloride or placebo intervention. To ascertain that the same area was scored at base line and at month 6, polyps were counted in pairs of photographs. One investigator, other than the endoscopist, who did not know the treatment, performed the scoring. Videotapes were used to resolve ambiguities and confirm polyp counts. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.	From baseline to 6 months.