Acupuncture for breast cancer related lymphedema: A randomized controlled trial.

Abstract

e21706 Background: Up to 20% of breast cancer survivors develop breast cancer related lymphedema (BCRL), and current therapies are limited. In a previous single armed study, acupuncture appeared to reduce BCRL. In this study, we compared our specific protocol of acupuncture (AC) to usual care wait list control (WL). Methods: Women with moderate persistent BCRL were randomized to AC or WL. The AC protocol included twice-weekly manual acupuncture over 6 weeks. The primary endpoint was change in circumference difference between affected/unaffected arms. Responders were defined as having > 30% improvement in arm circumference difference between arms. We also evaluated the change in difference between affected/unaffected arm bioimpedance. We used analysis of covariance for circumference and bioimpedance measurements and Fisher’s exact test for proportion of responders. Results: Among 82 patients, 73 (89%) were evaluable for the primary endpoint (36 in AC and 37 in WL). The median age in AC was 65 (IQR 54, 71) and 58 (IQR 49, 70) in WL. Most patients in both arms had undergone mastectomy (74%) and axillary lymph node dissection (96%), and had a history of prior lymphedema treatment (96%). Median duration of lymphedema was 2.2 years in AC (IQR 1.3, 3.0) and 2.5 years in WL (IQR 1.4, 3.4). We found no evidence of a difference in either arm circumference difference improvement (β -0.38cm, 95% CI -0.89, 0.12, p = 0.14) or bioimpedance difference improvement (β -1.06, 95% CI -7.85, 5.72, p = 0.8) between AC and WL at Week 6. There was also no difference in proportion of responders: 17% AC vs. 11% WL (6% difference, 95% CI -10%, 22%, p = 0.5). No severe adverse events (AE) were reported. Grade 1 treatment-related AEs such as bruising (58%), hematoma (2%), and pain (2%) were reported in patients receiving AC. Among the 837 acupuncture treatments provided, one possibly related grade 2 skin infection was reported. Conclusions: Although it appears to be safe and well tolerated, our acupuncture protocol did not offer additional clinically meaningful reductions in BCRL compared with usual care among patients who had received lymphedema treatment. This regimen should not be recommended for breast cancer survivors with persistent BCRL. Clinical trial information: NCT01706081.