Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy: Statistical analysis plan for a multicenter trial

Abstract

Background: Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, which make it challenging for them to adhere to treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy. Objective: To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical analysis plan (SAP) is intended to enhance the transparency and research quality of our randomized controlled trial. Methods: Our study is a multicenter, double-blind, randomized controlled clinical trial. This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula. To attenuate possible selection bias in the final report, we declared the overall trial design, outcome measures, subgroup analyses, and safety measures. Also, we described the data management and statistical analysis methods in detail. Conclusion: The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods. Further post-hoc analyses can be performed by referring to the SAP, and possible selection bias can be attenuated.

Keywords

• Statistical analysis plan
• Colon cancer
• Chemotherapy
• Randomized controlled trial
• Traditional Chinese medicine
• Capecitabine