Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

NCT03333265 | Completed Phase 2

• 1 other identifier: XJLL 2016 017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenomas

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

100mg Berberine hydrochloride group

EXPERIMENTAL

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

Drug: 100mg Berberine hydrochloride

300mg Berberine hydrochloride group

EXPERIMENTAL

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

Drug: 300mg Berberine hydrochloride

Placebo oral tablets

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

100mg Berberine hydrochloride DRUG

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

Also known as: 100mg Berberine hydrochloride tablet ("Sine Tianping")

100mg Berberine hydrochloride group

300mg Berberine hydrochloride DRUG

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

Also known as: 300mg Berberine hydrochloride tablet ("Sine Tianping")

300mg Berberine hydrochloride group

Placebo Oral Tablet DRUG

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

Also known as: Placebo (for Berberine hydrochloride)

Placebo oral tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Li

Xi'an, Shaanxi, 710000, China

Location

Study Officials

• Weizhong Wang, MD,PH.D

  Xijing digestive surgery center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of colorectal surgery center

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: September 1, 2017
• Primary Completion: August 31, 2020
• Study Completion: June 1, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

CN (1)