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 treat...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.展开更多
Background The side effects of chemotherapy-induced nausea and vomiting(CINV)and myelosuppression reduce the cancer patients’adherence to chemotherapy.Many Chinese patients choose Chinese medicine(CM)during chemother...Background The side effects of chemotherapy-induced nausea and vomiting(CINV)and myelosuppression reduce the cancer patients’adherence to chemotherapy.Many Chinese patients choose Chinese medicine(CM)during chemotherapy to reduce side effects;however,the evidence is lacking.The efficacy of a CM herbal treatment protocol,Jianpi Bushen Sequential Formula(健脾补肾续贯方,JBSF)will be evaluated on chemotherapy completion rate among patients with colon cancer.Methods A multi-center double-blind randomized controlled trial(RCT)will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine(CAPEOX).Patients will be randomized 1:1 to receive the JBSF or placebo formula.The primary outcome is the overall chemotherapy completion rate.The secondary outcomes include individual chemotherapy completion rate,4-cycle completion rate of chemotherapy,time to treatment failure,relative dose intensity and treatment toxicity.Follow-up visits will be scheduled before every and after last chemotherapy.Discussion This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer.(Trial registration:Clinical Trials.gov,No.NCT03716518)。展开更多
基金funded by the Key R&D project of the Ministry of Science and Technology,China(2017YFC1700604).
文摘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.
文摘Background The side effects of chemotherapy-induced nausea and vomiting(CINV)and myelosuppression reduce the cancer patients’adherence to chemotherapy.Many Chinese patients choose Chinese medicine(CM)during chemotherapy to reduce side effects;however,the evidence is lacking.The efficacy of a CM herbal treatment protocol,Jianpi Bushen Sequential Formula(健脾补肾续贯方,JBSF)will be evaluated on chemotherapy completion rate among patients with colon cancer.Methods A multi-center double-blind randomized controlled trial(RCT)will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine(CAPEOX).Patients will be randomized 1:1 to receive the JBSF or placebo formula.The primary outcome is the overall chemotherapy completion rate.The secondary outcomes include individual chemotherapy completion rate,4-cycle completion rate of chemotherapy,time to treatment failure,relative dose intensity and treatment toxicity.Follow-up visits will be scheduled before every and after last chemotherapy.Discussion This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer.(Trial registration:Clinical Trials.gov,No.NCT03716518)。
