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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial

Authors: Qi-wei Li, Ming-wei Yu, Guo-wang Yang, Xiao-min Wang, Huan Wang, Chen-xi Zhang, Na Xue, Wei-ru Xu, Qi Fu, Zhong Yang, Lin Yang

Published in: Trials | Issue 1/2017

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Abstract

Background

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV, but it is not easy to translate to practical application, owing to financial issues, provider-related barriers, and patient factors. Nondrug therapies are needed to alleviate the symptoms of CINV. Acupuncture is an appropriate adjunctive treatment for CINV, but additional evidence is needed.

Methods/design

This study is a multicenter, randomized, sham-controlled prospective clinical trial. A total of 136 participants will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. All treatment will be given for 5 days. Participants in both groups will receive acupuncture sessions twice on the first day of chemotherapy and once consecutively on the following 4 days. Each session takes approximately 30 minutes. The primary outcome measure will be the Common Terminology Criteria for Adverse Events to assess CINV. The secondary outcome measures will be the Eastern Cooperative Oncology Group score, Simplified Nutritional Appetite Questionnaire, and Hospital Anxiety and Depression scale. Safety will be assessed at each visit.

Discussion

The results of this trial will provide clinical evidence for the effect and safety of acupuncture for CINV.

Trial registrations

ISRCTN Registry identifier: ISRCTN13287728). Registered on 28 February 2015.
ClinicalTrials.gov identifier: NCT02369107. Registered on 17 February 2015.
Appendix
Available only for authorised users
Literature
1.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: antiemesis. Version 1. Fort Washington: NCCN; 2013.
2.
Chan VT, Yeo W. Antiemetic therapy options for chemotherapy-induced nausea and vomiting in breast cancer patients. Breast Cancer (Dove Med Press). 2011;3:151–60.
3.
Inrhaoun H, Kullmann T, Elghissassi I, Mrabti H, Errihani H. Treatment of chemotherapy-induced nausea and vomiting. J Gastrointest Cancer. 2012;43(4):541–6.CrossRefPubMed
4.
Roila F, Hesketh PJ, Herrstedt J. Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol. 2006;17(1):20–8.PubMed
5.
Hilarius DL, Kloeg PH, van der Wall E, van den Heuvel JJ, Gundy CM, Aaronson NK. Chemotherapy-induced nausea and vomiting in daily clinical practice: a community hospital-based study. Support Care Cancer. 2012;20(1):107–17.CrossRefPubMed
6.
Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187–98.CrossRefPubMed
7.
Hawkins R, Grunberg S. Chemotherapy-induced nausea and vomiting: challenges and opportunities for improved patient outcomes. Clin J Oncol Nurs. 2009;13(1):54–64.CrossRefPubMed
8.
Navari RM. Management of chemotherapy-induced nausea and vomiting: focus on newer agents and new uses for older agents. Drugs. 2013;73(3):249–62.CrossRefPubMed
9.
Lin SJ, Hatoum HT, Buchner D, Cox D, Balu S. Impact of 5-HT3 receptor antagonists on chemotherapy-induced nausea and vomiting: a retrospective cohort study. BMC Health Serv Res. 2012;12:215.CrossRefPubMedPubMedCentral
10.
Grunberg SM. Obstacles to the implementation of antiemetic guidelines. J Natl Compr Canc Netw. 2009;7(5):601–5.PubMed
11.
Salsman JM, Grunberg SM, Beaumont JL, Rogers M, Paul D, Clayman ML, et al. Communicating about chemotherapy-induced nausea and vomiting: a comparison of patient and provider perspectives. J Natl Compr Canc Netw. 2012;10(2):149–57.PubMed
12.
Rithirangsriroj K, Manchana T, Akkayagorn L. Efficacy of acupuncture in prevention of delayed chemotherapy induced nausea and vomiting in gynecologic cancer patients. Gynecol Oncol. 2015;136(1):82–6.CrossRefPubMed
13.
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.CrossRefPubMed
14.
Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, et al. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013;31(7):952–60.CrossRefPubMedPubMedCentral
15.
Yang X, Zhang S. A randomized control study on the clinical effects of ramosetron in prophylaxis of nausea and vomiting induced by cisplatin chemotherapy in patients with lung cancer [in Chinese]. Zhongguo Fei Ai Za Zhi. 2005;8(4):322–5.PubMed
16.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral
17.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–55.CrossRefPubMed
18.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
19.
Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, et al. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005;82(5):1074–81.PubMed
Metadata
Title
Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial
Authors
Qi-wei Li
Ming-wei Yu
Guo-wang Yang
Xiao-min Wang
Huan Wang
Chen-xi Zhang
Na Xue
Wei-ru Xu
Qi Fu
Zhong Yang
Lin Yang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1927-2

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