Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial

Chien-Hung Yeh, Tian Yi Zhao, Mei Dan Zhao, Yue Wu, Yong Ming Guo, Zhan Yu Pan, Ren Wei Dong, Bo Chen, Bin Wang, Jing Rong Wen, Dan Li, Yi Guo, Xing Fang Pan, Chien-Hung Yeh, Tian Yi Zhao, Mei Dan Zhao, Yue Wu, Yong Ming Guo, Zhan Yu Pan, Ren Wei Dong, Bo Chen, Bin Wang, Jing Rong Wen, Dan Li, Yi Guo, Xing Fang Pan

Abstract

Background: Lymphedema is the most common complication after breast cancer treatment, but management of lymphedema remains a clinical challenge. Several studies have reported the beneficial effect of acupuncture for treating breast cancer-related lymphedema (BCRL). Our objective is to verify the effectiveness of warm acupuncture on BCRL and compare the effectiveness of a local distribution acupoint combination with a local-distal acupoint combination for BCRL.

Methods: This is a study protocol for a multicenter, three-arm parallel, assessor blinded, randomized controlled trial. A total of 108 participants diagnosed as BCRL will be randomly allocated in equal proportions to a local distribution acupoint (LA) group, a local-distal acupoint (LDA) group, or a waiting-list (WL) group. The LA and LDA groups will receive 20 acupuncture treatment over 8 weeks with local distribution acupoint combination and local-distal acupoint combination, respectively. The WL group will receive acupuncture treatment after the study is concluded. The primary outcome is the mean change in inter-limb circumference difference from baseline to week 8. The secondary outcomes include volume measurement, skin hardness, common terminology criteria for adverse events 4.03 (edema limbs criteria), stages of lymphedema from the International Society of Lymphology, Disabilities of the Arm, Shoulder and Hand questionnaire, and the Medical Outcome Study 36-item Short-form Health Survey.

Discussion: This study aims to provide data on warm acupuncture as an effective treatment for BCRL and at the same time compare the effectiveness of different acupoint combinations.

Trial registration: ClinicalTrials.gov: Identifier NCT03373474 . Registered on 14th December 2017.

Keywords: Acupuncture; Breast cancer; Lymphedema.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Acupuncture points used in the study

References

    1. DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013;14(6):500–515. doi: 10.1016/S1470-2045(13)70076-7.
    1. Maunsell E, Brisson J, Deschenes L. Arm problems and psychological distress after surgery for breast cancer. Canadian journal of surgery. Can J Surg. 1993;36(4):315–320.
    1. Greenlee H, DuPont-Reyes MJ, Balneaves LG, Carlson LE, Cohen MR, Deng G, et al. Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment. CA Cancer J Clin. 2017;67(3):194–232. doi: 10.3322/caac.21397.
    1. Zia FZ, Olaku O, Bao T, Berger A, Deng G, Fan AY, et al. The National Cancer Institute’s Conference on Acupuncture for Symptom Management in Oncology: state of the science, evidence, and research gaps. J Natl Cancer Inst Monogr. 2017;2017(52). 10.1093/jncimonographs/lgx005.
    1. Yao C, Xu Y, Chen L, Jiang H, Ki CS, Byun JS, et al. Effects of warm acupuncture on breast cancer-related chronic lymphedema: a randomized controlled trial. Curr Oncol. 2016;23(1):E27–E34. doi: 10.3747/co.23.2788.
    1. Jeong YJ, Kwon HJ, Park YS, Kwon OC, Shin IH, Park SH. Treatment of lymphedema with saam acupuncture in patients with breast cancer: A pilot study. Med Acupunct. 2015;27(3):206–215. doi: 10.1089/acu.2014.1071.
    1. Smith CA, Pirotta M, Kilbreath S. A feasibility study to examine the role of acupuncture to reduce symptoms of lymphoedema after breast cancer: a randomised controlled trial. Acupunct Med. 2014;32(5):387–393. doi: 10.1136/acupmed-2014-010593.
    1. Cassileth BR, Van Zee KJ, Yeung KS, Coleton MI, Cohen S, Chan YH, et al. Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study. Cancer. 2013;119(13):2455–2461. doi: 10.1002/cncr.28093.
    1. de Valois BA, Young TE, Melsome E. Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. Eur J Oncol Nurs. 2012;16(3):301–309. doi: 10.1016/j.ejon.2011.07.005.
    1. Cassileth BR, Van Zee KJ, Chan Y, Coleton MI, Hudis CA, Cohen S, et al. A safety and efficacy pilot study of acupuncture for the treatment of chronic lymphoedema. Acupunct Med. 2011;29(3):170–172. doi: 10.1136/aim.2011.004069.
    1. BENDA K. The diagnosis and treatment of peripheral lymphedema: 2016 consensus document of the International Society of Lymphology. Lymphology. 2016;49:170–84.
    1. Chen YW, Tsai HJ, Hung HC, Tsauo JY, et al. Reliability study of measurements for lymphedema in breast cancer patients. Am J Phys Med Rehabil. 2008;87(1):33–38. doi: 10.1097/PHM.0b013e31815b6199.
    1. Megens AM, Harris SR, Kim-Sing C, McKenzie DC. Measurement of upper extremity volume in women after axillary dissection for breast cancer. Arch Phys Med Rehabil. 2001;82(12):1639–1644. doi: 10.1053/apmr.2001.26822.
    1. Killaars RC, Penha TR, Heuts EM, van der Hulst RR, Piatkowski AA. Biomechanical properties of the skin in patients with breast cancer-related lymphedema compared to healthy individuals. Lymphat Res Biol. 2015;13(3):215–221. doi: 10.1089/lrb.2014.0049.
    1. US department of Health and Human Services. National Cancer Institute: National Institutes of Health (2010). Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. National Institutes of Health. 2010. . Accessed 16 Jul 2018.
    1. Harrington S, Michener LA, Kendig T, Miale S, George SZ. Patient-reported upper extremity outcome measures used in breast cancer survivors: a systematic review. Arch Phys Med Rehabil. 2014;95(1):153–162. doi: 10.1016/j.apmr.2013.07.022.
    1. Liao CL, Wang C, Zhou X, Wang XJ. Checkout reliability and validity of Chinese version of DASH short form scale applied in upper limb dysfunction evaluation research of breast cancer patients [in Chinese] Chin Nurs Res. 2014;28(10):3581–3583.
    1. Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013;7(1):83–92. doi: 10.1007/s11764-012-0247-5.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–483. doi: 10.1097/00005650-199206000-00002.
    1. Li L, Wang HM, Shen Y. Development and psychometric tests of a Chinese version of the SF-36 Health Survey Scales [in Chinese] Chin J Prev Med. 2002;36(2):109–113.
    1. Greenslade MV, House CJ. Living with lymphedema: a qualitative study of women's perspectives on prevention and management following breast cancer-related treatment. Can Oncol Nurs J. 2006;16(3):165–179. doi: 10.5737/1181912x163165171.
    1. Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, et al. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015;5:CD003475.
    1. Boris M, Weindorf S, Lasinski B, Boris G. Lymphedema reduction by noninvasive complex lymphedema therapy. Oncology (Williston Park) 1994;8(9):95–106.
    1. Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850–859. doi: 10.1080/02841860902755251.
    1. Basta MN, Fox JP, Kanchwala SK, et al. Complicated breast cancer-related lymphedema: evaluating health care resource utilization and associated costs of management. Am J Surg. 2016;211(1):133–141. doi: 10.1016/j.amjsurg.2015.06.015.
    1. Rockson S. Current concepts and future directions in the diagnosis and management of lymphatic vascular disease. Vasc Med. 2010;15(3):223–231. doi: 10.1177/1358863X10364553.
    1. Li K, Zhang Z, Liu NF, Feng SQ, Tong Y, Zhang JF, et al. Efficacy and safety of far infrared radiation in lymphedema treatment: clinical evaluation and laboratory analysis. Lasers Med Sci. 2017;32(3):485–494. doi: 10.1007/s10103-016-2135-0.

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