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Berberine prevents postoperative recurrence of colorectal cancer: a protocol for a multicenter, double-blind,
Yulin Li1, Lingyu Zhang2, Han Tong1
1The Second Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Introduction:
Postoperative recurrence and metastasis of colorectal cancer (CRC) are critical factors affecting long-term survival, and how to prevent postoperative recurrence and metastasis remains an urgent clinical challenge. Studies indicate that berberine has a preventive effect against colorectal adenoma recurrence; however, no research has yet investigated its preventive efficacy against CRC. This trial aims to evaluate the clinical efficacy and safety of BBR in preventing postoperative recurrence and metastasis of CRC by comparing it with a placebo group.
Methods And Analysis:
This trial is a multicenter, randomized, controlled, double-blind clinical study. A total of 306 eligible patients with stage IIIB, IIIC CRC who had undergone surgery will be randomly assigned in a 1:1 ratio to the placebo group and the trial group. The primary outcome is 2-year disease-free survival (DFS) rate, while secondary outcomes include 1-year and 2-year postoperative recurrence rates of CRC, as well as the incidence of adverse reactions. We expect that this randomized controlled trial (RCT) will provide high-quality evidence on BBR for the prevention of postoperative recurrence of CRC, which can achieve more significant clinical benefits to patients with stage IIIB, IIIC CRC.
Ethics And Dissemination:
This study has been approved by the institutional review board of The Second Affiliated Hospital of Zhejiang Chinese Medical University (No. 2025-246-IH01).
Clinical Trial Registration:
www.chictr.org.cn, identifier: ChiCTR2600117441.
