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

Xijing Hospital of Digestive Diseases

Status and phase

Completed

Phase 3

Phase 2

Conditions

Colorectal Adenomas

Treatments

Drug: Placebo

Drug: Berberine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03281096

XJLL 2016 001

Details and patient eligibility

About

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.

Full description

The prevalence of colorectal adenomas is high in our country, as is the incidence of colorectal cancer. It is well-known that colorectal adenomas are the precursor of colorectal cancer and that removing them will prevent colorectal cancer. Because most colorectal cancers arise from benign adenomas, adenomas have been used as surrogate end points in prevention trials. Berberine hydrochloride, which is an alkaloid extracted from Rhizoma coptidis, has been traditionally used in Chinese medicine to treat gastrointestinal infections, due to its antimicrobial properties. Previous clinical research and animal studies have demonstrated the anti-tumor action of Berberine hydrochloride. Persons with a history of colorectal cancer might constitute a group at higher risk for adenomas and thus be particularly suitable for a study of the chemopreventive effects of Berberine hydrochloride. Here, a randomized, double-blind, placebo-controlled trial was designed to determine whether the daily use of 300 mg of berberine hydrochloride could decreases the occurrence of new colorectal adenomas among patients with a history of colorectal cancer.

Enrollment

1,000 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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