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 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, colon cancer, chemotherapy induced nausea and vomiting, myelosuppression
Acknowledgements
The authors appreciate MAO Jun, LIU Jian-ping, YANG Pei-ying, LI Qing, and YANG Ge-liang for their contributions to this study and this paper.
Footnotes
Conflict of Interest
The authors declare that there is no conflict of interest regarding the publication of this paper.
References
- 1.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. doi: 10.3322/caac.21492. [DOI] [PubMed] [Google Scholar]
- 2.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. [Google Scholar]
- 3.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. pp. 54–56. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.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. doi: 10.6004/jnccn.2018.0021. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Expert Committee on Rational Drug Use of National HealthFamily Planning Commission Guidelines for rational use of drugs in gastrointestinal cancer. Chin J Ration Frug Use (Chin) 2017;14:5–54. [Google Scholar]
- 6.Cancer RehabilitationPalliative 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. [Google Scholar]
- 7.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. [Google Scholar]
- 8.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. [Google Scholar]
- 9.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. doi: 10.1177/082585979100700202. [DOI] [PubMed] [Google Scholar]
- 10.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. doi: 10.1111/j.1365-2753.2011.01753.x. [DOI] [PubMed] [Google Scholar]
- 11.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. doi: 10.1056/NEJMoa1713709. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.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. doi: 10.1136/esmoopen-2016-000087. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.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. [Google Scholar]
- 14.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. doi: 10.2217/pme.11.39. [DOI] [PubMed] [Google Scholar]
- 15.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. doi: 10.1136/bmjebm-2018-110901. [DOI] [PubMed] [Google Scholar]
- 16.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. doi: 10.1136/bmj.m606. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.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. doi: 10.1002/jmv.25706. [DOI] [PMC free article] [PubMed] [Google Scholar]