A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

NCT03281096 | Completed Phase 2

• 1 other identifier: XJLL 2016 001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental studies in animals and observational studies in humans suggest that fusobacterium nucleatum is associates with stages of colorectal neoplasia development, and Berberine Hydrochloride could rescue Fusobacterium nucleatum-induced colorectal tumorigenesis by modulating the tumor microenvironment. Whether regular Berberine Hydrochloride use may decrease the risk of colorectal adenomas, the precursors to most colorectal cancers is worth to further study.

Conditions

Colorectal Adenomas

Outcome Measures

Primary Outcomes (1)

• Cumulative the colorectal adenoma incidence rate during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer

  The proportion of patients in whom one or more colorectal adenomas were investigated during the period from one year after randomization through the anticipated surveillance follow-up examination. The development of colorectal adenomas was assessed with an Olympus flexible video colonoscopy. One endoscopic investigator, who did not review the records of previous examinations, made all the assessments.

  From baseline to 3 years.

Secondary Outcomes (1)

• Cumulative the numbers or diameters of those new colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer

  From baseline to 3 years.

Study Arms (2)

Berberine hydrochloride group

EXPERIMENTAL

Berberine hydrochloride 300mg tablet by mouth, two times per day for 3 years

Drug: Berberine hydrochloride

Placebo

PLACEBO COMPARATOR

identical-appearing placebo 300mg tablet by mouth, two times per day for 3 years

Drug: Placebo

Interventions

Berberine hydrochloride DRUG

patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.

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

Berberine hydrochloride group

Placebo DRUG

pill manufactured to mmic Berberine hydrochloride 100mg tablet

Also known as: Placebo (for Berberine hydrochloride)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• Patients who had histologically documented colon or rectal cancer with a low risk of recurrent disease
• Patients with Dukes' stage A or B1 colon or rectal cancer (tumor-node-metastasis \[TNM\] stage T1 to T2, N0, M0) who had undergone curative resection of the primary tumor were immediately eligible for enrollment
• Patients with Dukes' stage B2 or C (T3 to T4, N0 to N1, M0) colon or rectal cancer who had undergone curative resection of the primary tumor were eligible if they had been free of disease for more than five years after curative surgery
• Eligible participants had to have undergone, after adequate preparation, colonoscopy to the cecum (or small-bowel anastomosis), with removal of all polyps, within four months before study entry
• Patients were eligible if they were in good general health, with an expected survival of at least five years; willing to provide and able to understand informed consent and to cooperate with the study procedures; not currently enrolled in a clinical trial of colon-cancer treatment or other chemoprevention trial; and not pregnant or nursing.

You may not qualify if:

• Patients who are hypersensitive or intolerant to the drugs
• Patients had familial polyposis
• Patients had invasive cancer other than nonmelanoma skin cancer within 5 years before the intake appointment
• 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 had a history of inflammatory bowel disease
• Patients with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency
• Patients had received immunosuppressive therapy within the previous 6 months
• 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
• Patients with any condition that could be worsened by supplemental Berberine hydrochloride

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, 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: August 30, 2017
• First Posted: September 13, 2017
• Study Start: August 29, 2017
• Primary Completion: October 12, 2020
• Study Completion: March 1, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

CN (1)