Clinical trial NCT02226185: Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence
Official title: A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Adenoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Recurrence rates of CRA
timeFrame: until the last patient reached the 2 years follow-up
Secondary outcomes:
measure: The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer
timeFrame: until the last patient reached the 2 years follow-up
Other outcomes:
measure: Changes in fecal microflora
timeFrame: baseline, the 1st year and the 2nd year
Locations:
city: Beijing
country: China
facility: Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
state: Beijing
city: Xiamen
country: China
facility: Department of Gastroenterology, Zhongshan Hospital, Xiamen University
state: Fujian
city: Guangdong
country: China
facility: Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
state: Guangzhou
city: Nanjing
country: China
facility: Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
state: Jiangsu
city: Shanghai
country: China
facility: 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
state: Shanghai
city: Shanghai
country: China
facility: Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
state: Shanghai
city: Tianjin
country: China
facility: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
state: Tianjin
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jing-Yuan Fang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY. Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):267-275. doi: 10.1016/S2468-1253(19)30409-1. Epub 2020 Jan 8.