Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial

Huiru Zhu, Jinwan Li, Zheng Peng, Yujie Huang, Xiaolan Lv, Liuying Song, Gechen Zhou, Shengzhang Lin, Jifei Chen, Baoyu He, Fengxian Qin, Xumexiang Liu, Meiyu Dai, Yan Zou, Shengming Dai, Huiru Zhu, Jinwan Li, Zheng Peng, Yujie Huang, Xiaolan Lv, Liuying Song, Gechen Zhou, Shengzhang Lin, Jifei Chen, Baoyu He, Fengxian Qin, Xumexiang Liu, Meiyu Dai, Yan Zou, Shengming Dai

Abstract

Background: Although various treatments for breast cancer related lymphedema exist, there is still a need for a more effective and convenient approach. Pilot studies and our clinical observations suggested that acupuncture may be a potential option. This study aims to verify the effectiveness of acupuncture on BCRL and evaluate its safety using a rigorously designed trial.

Methods/design: Women who are clinically diagnosed as unilateral BCRL, with a 10% to 40% increase in volume compared to the unaffected arm, will be recruited. Following baseline assessment, participants will be randomized to either the real acupuncture group or sham-acupuncture group at a ratio of 1:1, and given a standard real acupuncture or sham-acupuncture treatment accordingly on both arms followed by the same usual care of decongestive therapy. Volume measurements of both arms will be performed for every participant after each treatment. Data collected at baseline and the last session will be used to calculate the primary outcome and secondary outcomes. Other data will be exploited for interim analyses and trial monitoring. The primary outcome is the absolute reduced limb volume ratio. Secondary outcomes are incidence of adverse events and change in quality of life. A t test or non-parameter test will be used to compare the difference between two groups, and assess the overall effectiveness of acupuncture using the SPSS software (version 12).

Discussion: This study will help expand our knowledge about the effectiveness of acupuncture on BCRL, and how acupuncture might be used in the management of this condition. Acupuncture may be a promising complement or alternative to conventional lymphedema treatment methods, if its effectiveness is confirmed.

Trial registration: ClinicalTrials.gov NCT02803736 (Registered on October 31, 2016).

Keywords: Acupuncture; Breast cancer related lymphedema; Protocol; Trial.

Conflict of interest statement

Ethics approval and consent to participate

The trial was approved by the Institutional Review Board of the Fourth Affiliated Hospital of Guangxi Medical University (Approval Number: PJK2016090). All participants will provided written, signed informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of selected acupoints in this trial. Participants will receive real acupuncture or sham-acupuncture at the same acupoints in both arms 3 times a week for 4 weeks (12 sessions)
Fig. 2
Fig. 2
Structure of Streitberger needle. (1) Needle handle (2) Needle rod (3) Blunt tip of the placebo needle (4) Plastic ring (5) Plastic cover (6) Sharp tip of the real needle

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