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Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer:Study Protocol for a Randomized Controlled Trial

查看全文 作  者:ZHANG [1]Tong;FEI Yu-[2]tong;XU [1]Yun;SUN Ling-[1]yun;HE [1]Bin;YAN Shao-[1]hua;TANG [1]Mo;YAN Yun-[1]zi;MAO [3]Jun;YANG Yu-[1]fei 高影响力作者 机构地区:[1]Department of Oncology,Xiyuan Hospital of China Academy of Chinese Medicine Sciences,Beijing(100091),China;[2]Centre for Evidence-Based Chinese Medicine,Beijing University of Traditional Chinese Medicine,Beijing(100029),China;[3]Integrative Medicine Service,Memorial Sloan Kettering Cancer Center,New York(10041 NY 212),United States高影响力机构 出  处:《Chinese Journal of Integrative Medicine》索引2021年第27卷第12期,共5页高影响力期刊 摘  要: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)。 关 键 词:Chinese medicine Jianpi Bushen Sequential Formula Liujun Anwei Formula Qitu Erzhi Formula colon cancer chemotherapy induced nausea and vomiting MYELOSUPPRESSION
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