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Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

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ClinicalTrials.gov Identifier: NCT03333265
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
xiaohua li, Xijing Hospital of Digestive Diseases

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.

Condition or disease Intervention/treatment Phase
Colorectal Adenomas Drug: 100mg Berberine hydrochloride Drug: 300mg Berberine hydrochloride Drug: Placebo Oral Tablet Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: 100mg Berberine hydrochloride group
Berberine hydrochloride 100mg tablet by mouth, two times per day for 6 months
Drug: 100mg Berberine hydrochloride
patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months
Other Name: 100mg Berberine hydrochloride tablet ("Sine Tianping")

Experimental: 300mg Berberine hydrochloride group
Berberine hydrochloride 300mg tablet by mouth, two times per day for 6 months
Drug: 300mg Berberine hydrochloride
patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months
Other Name: 300mg Berberine hydrochloride tablet ("Sine Tianping")

Placebo Comparator: Placebo oral tablets
identical-appearing placebo tablets by mouth, two times per day for 6 months
Drug: Placebo Oral Tablet
patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months
Other Name: Placebo (for Berberine hydrochloride)




Primary Outcome Measures :
  1. Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis [ Time Frame: From baseline to 6 months. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333265


Contacts
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Contact: xiaohua li, MD,PH.D +8613474299901 xjyylixiaohua@163.com
Contact: ying zhang, MD,PH.D +8613310980140 xjyywcwk@163.com

Locations
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China, Shaanxi
Xijing Hospital of Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: xiaohua li, MD, PH.D    13474299901    lixiaohua1982@fmmu.edu.cn   
Contact: ying zhang, MD, PH.D    13310980140      
Sponsors and Collaborators
xiaohua li
Investigators
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Principal Investigator: Weizhong Wang, MD,PH.D Xijing digestive surgery center

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Responsible Party: xiaohua li, Director of colorectal surgery center, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03333265     History of Changes
Other Study ID Numbers: XJLL 2016 017
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Adenoma
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn