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

Tong Zhang, Yu-Tong Fei, Yun Xu, Ling-Yun Sun, Bin He, Shao-Hua Yan, Mo Tang, Yun-Zi Yan, Jun Mao, Yu-Fei Yang, Tong Zhang, Yu-Tong Fei, Yun Xu, Ling-Yun Sun, Bin He, Shao-Hua Yan, Mo Tang, Yun-Zi Yan, Jun Mao, Yu-Fei Yang

Abstract

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 (, 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: ClinicalTrials.gov, No. NCT03716518).

Keywords: Chinese medicine; Jianpi Bushen Sequential Formula; Liujun Anwei Formula; Qitu Erzhi Formula; chemotherapy induced nausea and vomiting; colon cancer; myelosuppression.

© 2021. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature.

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Source: PubMed

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