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Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02226185
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Drug: Berberine hydrochloride Drug: placebo Phase 2 Phase 3

Detailed Description:

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas
Actual Study Start Date : November 2014
Actual Primary Completion Date : December 29, 2018
Actual Study Completion Date : December 29, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
 Drug: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Placebo Comparator: placebo
identical-appearing placebo supplements for 2-3 years
 Drug: placebo
supplement of placebo two times per day for 2-3 years


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rates of CRA [ Time Frame: until the last patient reached the 2 years follow-up ]
    The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.


Secondary Outcome Measures :
  1. The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer [ Time Frame: until the last patient reached the 2 years follow-up ]
    The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention


Other Outcome Measures:
  1. Changes in fecal microflora [ Time Frame: baseline, the 1st year and the 2nd year ]
    Fecal microflora tests


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Individuals aged 18-75 years
  • Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment
  • Individuals who are able to swallow pills
  • Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria
  • Individuals whose adenoma was not completely removed during previous colonoscopy
  • Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
  • Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D
  • Individuals with a history of subtotal/total gastrectomy or partial bowel resection
  • Individuals who are intolerant to another colonoscopy examination
  • Individuals who are hypersensitive or intolerant to the drugs
  • Individuals with severe heart, liver or kidney disease, or any cancer history
  • Individuals presenting severe constipation
  • Pregnant women, women during breast-feeding period, or women with expect pregnancy
  • Individuals with mental diseases who are not able to cooperate
  • Individuals who are involved in designing, planning or performing this trial
Contacts and Locations
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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): NCT02226185


Locations
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China, Beijing
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, Beijing, China
China, Fujian
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, Fujian, China
China, Guangzhou
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, Guangzhou, China
China, Jiangsu
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
Nanjing, Jiangsu, China
China, Shanghai
Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health
Shanghai, Shanghai, China, 200001
Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai, China
China, Tianjin
Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
Tianjin, Tianjin, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jing-Yuan Fang, M.D., Ph.D Shanghai Jiao Tong University School of Medicine
  Study Documents (Full-Text)

Documents provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] December 22, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jing-yuan Fang, MD, Ph. D, Director of Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02226185    
Other Study ID Numbers: RJ2014BH
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Adenoma
Recurrence
Disease Attributes
Pathologic Processes
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms