Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Lili Gao, Bo Chen, Qiwen Zhang, Tianyi Zhao, Bo Li, Tao Sha, Jinxin Zou, Yongming Guo, Xingfang Pan, Yi Guo, Lili Gao, Bo Chen, Qiwen Zhang, Tianyi Zhao, Bo Li, Tao Sha, Jinxin Zou, Yongming Guo, Xingfang Pan, Yi Guo

Abstract

Background: Acupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the effect of different acupoint combinations on controlling CINV remains unknown. This study aims to compare the effects of distal-proximal point association and local distribution point association on controlling CINV.

Methods/design: The study is a single-center, randomized controlled trial. A total of 240 participants will be randomly divided into four groups. The control group will receive standard antiemetic only, whereas three acupuncture groups will receive four electro-acupuncture treatments once a day with the standard antiemetic. Acupuncture group I and II will receive distal-proximal point association ("Neiguan (PC6) and Zhongwan (CV12)", and "Zusanli (ST36) and CV12", respectively); Acupuncture group III will receive local distribution point association ("Shangwan (CV13) and CV12"). The primary outcome measures are the frequency and distress of nausea and vomiting. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, quality of life, etc. Assessment is scheduled from the day before chemotherapy to the fifth day of chemotherapy. Follow-ups are performed from the sixth day to the twenty-first day of chemotherapy.

Discussion: Results of this trial will help in evaluating the efficacy and safety of electro-acupuncture with different acupoint combinations in the management of CINV.

Trial registration: ClinicalTrials.gov identifier: NCT02478047 .

Keywords: Acupoint combination; Acupuncture; Chemotherapy-induced nausea and vomiting; Randomized controlled trial.

Figures

Fig. 1
Fig. 1
Flow chart of the study

References

    1. Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, et al. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015;16(9):1071–8. doi: 10.1016/S1470-2045(15)00034-0.
    1. Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472–8. doi: 10.1200/JCO.2006.05.6382.
    1. Han G, Ko SJ, Park JW, Kim J, Yeo I, Lee H, et al. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial. Trials. 2014;15:89. doi: 10.1186/1745-6215-15-89.
    1. Wu X, Chung VC, Hui EP, Ziea ET, Ng BF, Ho RS, et al. Effectiveness of acupuncture and related therapies for palliative care of cancer: overview of systematic reviews. Sci Rep. 2015;5:16776. doi: 10.1038/srep16776.
    1. Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008;26(23):3903–10. doi: 10.1200/JCO.2007.15.9533.
    1. Zhao JS. Chinese acupuncture and moxibustion. 1st ed. Shanghai: Publishing house of Shanghai University of Traditional Chinese Medicine; 2002.
    1. Gottschling S, Reindl TK, Meyer S, Berrang J, Henze G, Graeber S, et al. Acupuncture to alleviate chemotherapy-induced nausea and vomiting in pediatric oncology-a randomized multicenter crossover pilot trial. Klin Padiatr. 2008;220(6):365–70. doi: 10.1055/s-0028-1086039.
    1. Shen J, Wenger N, Glaspy J, Hays RD, Albert PS, Choi C, et al. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. JAMA. 2000;284(21):2755–61. doi: 10.1001/jama.284.21.2755.
    1. Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011;29(31):4189–98. doi: 10.1200/JCO.2010.34.4614.
    1. World Health Organization, WHO standard acupuncture point locations in the Western Pacific Region. Manila: World Health Organization Regional Office for the Western Pacific; 2008.
    1. MacPherson H, Altman DG, Hammerschlag R, Li YP, Wu TX, White A, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. doi: 10.1371/journal.pmed.1000261.
    1. US Department of Health and Human Services, Common terminology criteria for adverse events (CTCAE) version 4.0. Bethesda: National Institutes of Health, National Cancer Institute; 2009.
    1. Rhodes VA, McDaniel RW. The index of nausea, vomiting, and retching: a new format of the index of nausea and vomiting. Oncol Nurs Forum. 1999;26(5):889–94.
    1. Fairclough DL, Cella DF. Functional Assessment of Cancer Therapy (FACT-G): non-response to individual questions. Qual Life Res. 1996;5(3):321–9. doi: 10.1007/BF00433916.
    1. Snaith RP. The hospital anxiety and depression scale. Health Qual Life Outcomes. 2003;1:29. doi: 10.1186/1477-7525-1-29.
    1. An Q, Chen B, Guo Y, Pan XF, Guo YM. A preliminary discussion on rules of clinical acupoint selection of acupuncture for the treatment of chemotherapy-induced nausea and vomiting. World J Acupunct Moxibustion. 2015;25(2):39–44. doi: 10.1016/S1003-5257(15)30048-9.
    1. Bao T. Use of acupuncture in the control of chemotherapy-induced nausea and vomiting. J Natl Compr Canc Netw. 2009;7(5):606–12.

Source: PubMed

3
Abonneren