健脾补肾序贯方对结肠癌辅助化疗的影响：一项随机对照试验的研究方案

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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健脾补肾序贯方对结肠癌辅助化疗的影响：一项随机对照试验的研究方案

Original Article | Updated：2021-11-29

- 健脾补肾序贯方对结肠癌辅助化疗的影响：一项随机对照试验的研究方案
- Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2021年27卷第12期页码：891-895
- 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
  中图分类号：
- 纸质出版日期：2021-11-15，
  
  网络出版日期：2021-08-25，
  
  录用日期：2021-01-11
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Tong ZHANG, Yu-tong FEI, Yun XU, 等. 健脾补肾序贯方对结肠癌辅助化疗的影响：一项随机对照试验的研究方案[J]. Chinese Journal of Integrative Medicine, 2021,27(12):891-895.

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, 2021,27(12):891-895.
Tong ZHANG, Yu-tong FEI, Yun XU, 等. 健脾补肾序贯方对结肠癌辅助化疗的影响：一项随机对照试验的研究方案[J]. Chinese Journal of Integrative Medicine, 2021,27(12):891-895. DOI： 10.1007/s11655-021-3448-9.

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, 2021,27(12):891-895. 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

references

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394-424.

Sun KX, Zheng RS, Zhang SW. Analysis of cancer incidence and death in different regions of China in 2015.Chin J Cancer 2019;28:1-11.

Guidelines Working Committee of Chinese society of Clinical Oncology. Chinese society of Clinical Oncology (CSCO)colorectal cancer diagnosis and treatment guidelines(2018.V1). Beijing: People's Health Press; 2018:54-56.

Benson AB, Venook AP, Al-Hawary MM, Cederquist L.NCCN guidelines insights: colon cancer, version 2. 2018. J Natl Compr Canc Netw 2018;16:359-369.

Expert Committee on Rational Drug Use of National Health and Family Planning Commission. Guidelines for rational use of drugs in gastrointestinal cancer. Chin J Ration Frug Use (Chin) 2017;14:5-54.

Cancer Rehabilitation and Palliative Treatment Committee of China Anti-Cancer Association. Guidelines for the prevention and treatment of vomiting related to tumor therapy (2014). J Clin Oncol 2014;19:263-273.

Fan K, Dai LM, Wu ZF, Yang GY, Yang M. Research progress of bone marrow suppression induced by radiotherapy and chemotherapy. Chin J Tradit Chin Med(Chin) 2017;32:210-214.

Dai LL, Chen DM, Zhou SM, Zhao N, Si WT, Cao Y,et al. "Two stage three step curve method" to assist in the prevention and treatment of chemotherapy adverse reactions of colorectal cancer. J Tradit Chin Med (Chin)2019;60:982-985.

Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 1991;7:6-9.

Wong CK, Lam CL, Law WL, Poon JT, Chan P, Kwong DL,Tsang J. Validity and reliability study on traditional Chinese FACT-C in Chinese patients with colorectal neoplasm. J Eval Clin Pract 2012;18:1186-1195.

Grothey A, Sobrero AF, Shields AF, Yoshino T, Iveson T. Duration of adjuvant chemotherapy for stage Ⅲ colon cancer. N Engl J Med 2018;378:1177-1188.

Lund CM, Nielsen D, Dehlendorff C, Christiansen AB,Ronholt F, Johansen JS, et al. Efficacy and toxicity of adjuvant chemotherapy in elderly patients with colorectal cancer: the ACCORE study. ESMO Open 2016;1(5):1-7.

Yang L, Wang JW, Cui CG, Zhang HG, Li YS, Huang J, et al. Tolerance of adjuvant chemotherapy with oxaliplatin in patients with colorectal cancer. J Cancer Prev Treat (Chin)2008;35:892-896.

Issa AM, Hutchinson JF, Tufail W, Fletcher E, Ajike R,Tenorio J. Provision of personalized genomic diagnostic technologies for breast and colorectal cancer: an analysis of patient needs, expectations and priorities. Per Med 2011;8:401-411.

Senore C, Haug U. Faecal immunochemical tests have the potential for correctly ruling out colorectal cancer in symptomatic patients. BMJ Evid Based Med 2018;23:113-114.

Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, et al.Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan,China: retrospective case series. BMJ 2020;368: m606.

Ayittey FK, Ayittey MK, Chiwero NB, Kamasah JS, Dzuvor C. Economic impacts of Wuhan 2019-nCoV on China and the world. J Med Virol 2020;92:473-475.

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