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Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Primary Purpose

Colorectal Adenomas

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

100mg Berberine hydrochloride

300mg Berberine hydrochloride

Placebo Oral Tablet

About this trial

This is an interventional prevention trial for Colorectal Adenomas

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18-65 years
Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically
All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations.
Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery

Exclusion Criteria:

Patients who are hypersensitive or intolerant to the drugs
Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization
Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter))
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 with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency
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
Individual who are involved in designing, planning or performing this clinical trial
Patients with medical conditions who are not appropriate to participate the study
Patients with any condition that could be worsened by supplemental Berberine hydrochloride

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

100mg Berberine hydrochloride group

300mg Berberine hydrochloride group

Placebo oral tablets

Arm Description

Berberine hydrochloride 100mg tablet by mouth, two times per day for 6 months

Berberine hydrochloride 300mg tablet by mouth, two times per day for 6 months

identical-appearing placebo tablets by mouth, two times per day for 6 months

Outcomes

Primary Outcome Measures

Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis

The primary objective of this study is to investigate the number and diameters of colorectal polyps after Berberine hydrochloride or placebo intervention. To ascertain that the same area was scored at base line and at month 6, polyps were counted in pairs of photographs. One investigator, other than the endoscopist, who did not know the treatment, performed the scoring. Videotapes were used to resolve ambiguities and confirm polyp counts. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.

Secondary Outcome Measures

Full Information

NCT ID

NCT03333265

First Posted

November 2, 2017

Last Updated

July 24, 2022

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT03333265

Brief Title

Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Official Title

The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

June 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

In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.

Detailed Description

Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer. BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis.

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

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100mg Berberine hydrochloride group

Arm Type

Experimental

Arm Description

Berberine hydrochloride 100mg tablet by mouth, two times per day for 6 months

Arm Title

300mg Berberine hydrochloride group

Arm Type

Experimental

Arm Description

Berberine hydrochloride 300mg tablet by mouth, two times per day for 6 months

Arm Title

Placebo oral tablets

Arm Type

Placebo Comparator

Arm Description

identical-appearing placebo tablets by mouth, two times per day for 6 months

Intervention Type

Drug

Intervention Name(s)

100mg Berberine hydrochloride

Other Intervention Name(s)

100mg Berberine hydrochloride tablet ("Sine Tianping")

Intervention Description

patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months

Intervention Type

Drug

Intervention Name(s)

300mg Berberine hydrochloride

Other Intervention Name(s)

300mg Berberine hydrochloride tablet ("Sine Tianping")

Intervention Description

patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

Placebo (for Berberine hydrochloride)

Intervention Description

patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Primary Outcome Measure Information:

Title

Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis

Description

Time Frame

From baseline to 6 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18-65 years Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations. Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery Exclusion Criteria: Patients who are hypersensitive or intolerant to the drugs Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter)) 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 with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency 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 Individual who are involved in designing, planning or performing this clinical trial Patients with medical conditions who are not appropriate to participate the study 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

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

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