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.
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Details
1 Tianjin University of Traditional Chinese Medicine, College of Acupuncture and Massage, Tianjin, China (GRID:grid.410648.f) (ISNI:0000 0001 1816 6218)
2 Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer, Department of Combined Chinese & Western Medicine, Tianjin, China (GRID:grid.411918.4) (ISNI:0000 0004 1798 6427)
3 Tianjin University of Traditional Chinese Medicine, Department of Traditional Chinese Medicine, Tianjin, China (GRID:grid.410648.f) (ISNI:0000 0001 1816 6218); Acupuncture Research Center of Tianjin University of Traditional Chinese Medicine, Tianjin, China (GRID:grid.410648.f) (ISNI:0000 0001 1816 6218)