Abstract
BackgroundAlthough 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/DesignWomen 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).DiscussionThis 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 registrationClinicalTrials.gov NCT02803736 (Registered on October 31, 2016).
Highlights
Various treatments for breast cancer related lymphedema exist, there is still a need for a more effective and convenient approach
This study will help expand our knowledge about the effectiveness of acupuncture on breast cancer related lymphedema (BCRL), and how acupuncture might be used in the management of this condition
As a long-term complication stemming from the disruption of lymph flow, breast cancer related lymphedema (BCRL) is a distressing problem afflicting around 20% of women who underwent breast cancer treatment, and is characterized by the chronic swelling of one or both upper extremities [1,2,3,4]
Summary
Various treatments for breast cancer related lymphedema exist, there is still a need for a more effective and convenient approach. Almost every patient experiencing breast cancer surgery is advised to take precautions and take good care of the affected arm to prevent lymphedema [12, 13]. All these things pose a reminder to patients of their malignant status and become a prominent psychosocial problem that afflicts breast cancer survivors [14, 15]. No consensus has been reached on any specific approach for BCRL [25], and the management of BCRL remains a major challenge for both physicians and patients [26]
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