Abstract
BackgroundLymphedema 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov: Identifier NCT03373474. Registered on 14th December 2017.
Highlights
Lymphedema is the most common complication after breast cancer treatment, but management of lymphedema remains a clinical challenge
This study aims to provide data on warm acupuncture as an effective treatment for breast cancer-related lymphedema (BCRL) and at the same time compare the effectiveness of different acupoint combinations
Several treatment options are available, including manual lymphatic drainage, compression bandaging, and complete decongestive therapy, a clinical guideline on the integrative therapies used after breast cancer treatment reported that there were no A-graded or Bgraded therapies to report for lymphedema [3]
Summary
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). Cassileth et al [8] performed a wholebody treatment that included acupoints on the abdomen, legs, and affected and unaffected arms, while Yao et al [5] performed acupuncture treatment on the affected arm only. Both acupuncture prescriptions were able to reduce arm circumference, which of the two provides better results remains unclear. We propose a multi-center, randomized controlled trial to determine the optimal acupoint combination for the treatment of BCRL
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