Colorectal AdenomasPhase 2/3NCT03281096
A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
A Phase 2/3 study testing Berberine hydrochloride in people with Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Adenomas
- What is being tested?
- Berberine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2017to 1 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Adenomas
- Being tested
- Berberine hydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine hydrochlorideDrug
Also called Berberine hydrochloride tablet ("Sine Tianping")
patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.
PlaceboDrug
Also called Placebo (for Berberine hydrochloride)
pill manufactured to mmic Berberine hydrochloride 100mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Berberine hydrochloride group | Experimental | Berberine hydrochloride 300mg tablet by mouth, two times per day for 3 years Receives: Drug: Berberine hydrochloride |
| Placebo | Placebo comparator | identical-appearing placebo 300mg tablet by mouth, two times per day for 3 years Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From baseline to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start29 Aug 2017
- Primary completion12 Oct 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- Weizhong Wang, MD,PH.D, Principal investigator, Xijing digestive surgery center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281096
- Sponsor's protocol ID
- XJLL 2016 001
- Status last verified
- Jul 2022
- First submitted
- 30 Aug 2017
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03281096
- Acronym / sponsor ID
- XJLL 2016 001
- Conditions
- Colorectal Adenomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine hydrochloride group | Experimental | Drug: Berberine hydrochlorideBerberine hydrochloride 300mg tablet by mouth, two times per day for 3 years |
| Placebo | Placebo comparator | Drug: Placeboidentical-appearing placebo 300mg tablet by mouth, two times per day for 3 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine hydrochlorideAlso: Berberine hydrochloride tablet ("Sine Tianping")patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years. | Drug | Berberine hydrochloride group |
| PlaceboAlso: Placebo (for Berberine hydrochloride)pill manufactured to mmic Berberine hydrochloride 100mg tablet | Drug | Placebo |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weizhong Wang, MD,PH.D principal investigator
Xijing digestive surgery center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Berberine hydrochloride in people with Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.