- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281096
A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
July 24, 2022 updated by: xiaohua li, Xijing Hospital of Digestive Diseases
A Randomized Trial of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Xijing Hospital of Digestive Disease
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Berberine hydrochloride group
Berberine hydrochloride 300mg tablet by mouth, two times per day for 3 years
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patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.
Other Names:
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Placebo Comparator: Placebo
identical-appearing placebo 300mg tablet by mouth, two times per day for 3 years
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pill manufactured to mmic Berberine hydrochloride 100mg tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative the colorectal adenoma incidence rate during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer
Time Frame: From baseline to 3 years.
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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.
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From baseline to 3 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative the numbers or diameters of those new colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer
Time Frame: From baseline to 3 years.
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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.
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From baseline to 3 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Weizhong Wang, MD,PH.D, Xijing digestive surgery center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2017
Primary Completion (Actual)
October 12, 2020
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 24, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJLL 2016 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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