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

Primary Purpose

Colorectal Adenomas

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Berberine hydrochloride

Placebo

About this trial

This is an interventional prevention trial for Colorectal Adenomas

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Xijing Hospital of Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine hydrochloride group

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The numbers or diameters of those new colorectal adenomas were analyzed during the period from one year after randomization through the anticipated surveillance follow-up examination. The endoscopic investigator, who did not review the records of previous examinations, counted the total number of colorectal adenomas, and the examination was recorded on videotape. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.

Full Information

NCT ID

NCT03281096

First Posted

August 30, 2017

Last Updated

July 24, 2022

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT03281096

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 29, 2017 (Actual)

Primary Completion Date

October 12, 2020 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Adenomas

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Berberine hydrochloride group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Berberine hydrochloride

Other Intervention Name(s)

Berberine hydrochloride tablet ("Sine Tianping")

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo (for Berberine hydrochloride)

Intervention Description

pill manufactured to mmic Berberine hydrochloride 100mg tablet

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From baseline to 3 years.

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From baseline to 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weizhong Wang, MD,PH.D

Organizational Affiliation

Xijing digestive surgery center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Disease

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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