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

doi:10.1007/s11655-021-3448-9

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

Original Article | Updated：2021-11-29

- Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 27, Issue 12, Pages: 891-895(2021)
- Affiliations：
  
  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
- Author bio：
  
  Prof. YANG Yu-fei, E-mail: yyf93@vip.sin.com
- Funds：
- DOI：10.1007/s11655-021-3448-9
  CLC：
- Published：15 November 2021，
  
  Published Online：25 August 2021，
  
  Accepted：11 January 2021
Scan for full text
Tong ZHANG, Yu-tong FEI, Yun XU, et al. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 27(12):891-895(2021)
DOI：

Tong ZHANG, Yu-tong FEI, Yun XU, et al. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 27(12):891-895(2021) DOI： 10.1007/s11655-021-3448-9.

摘要

背景:

化疗引起的恶心呕吐和骨髓抑制的降低了患者对化疗的依从性. 在中国

许多患者会在化疗期间同时接受中医治疗以减轻化疗的副作用

但是缺乏循证医学的支持. 本研究拟评估中药治疗方案 "健脾补肾序贯方" 对结肠癌患者化疗完成率的影响.

方法:

这是一项多中心、随机、双盲、随机对照临床研究

计划对400名结肠癌根治术后拟进行辅助化疗的患者进行8个周期的CAPEOX方案化疗

患者在化疗期间将以1: 1的比例随机接受健脾补肾序贯方或安慰剂. 主要结局指标是总体化疗完成率

次要结局指标包括个体化疗完成率、4周期化疗完成率、治疗失败时间、相对剂量强度和治疗相关毒性. 随访节点设置在每次化疗前和末次化疗后.

讨论:

这项研究将为健脾补肾续贯方能否提高结肠癌患者的化疗完成率和减少副作用提供证据.

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 (健脾补肾续贯方

JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.

Methods:

A multi-center doubleblind 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)

关键词

Keywords

Chinese medicineJianpi Bushen Sequential FormulaLiujun Anwei FormulaQitu Erzhi Formulacolon cancerchemotherapy induced nausea and vomitingmyelosuppression

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Second Department of Oncology, Traditional Chinese Medicine Hospital of Xinjiang Uyghur Autonomous Region

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State Key Laboratory of Cellular Stress Biology, School of Life Sciences, Faculty of Medicine and Life Science, Xiamen University

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