Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer

Abstract

To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25 % white, 25 % black, and 43 % Hispanic; 52 % had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, P = .86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (SEA 1.7 vs. EA 3.4, P = .03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (P = .04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.

Keywords: Acupuncture; Breast cancer; Chemotherapy-induced peripheral neuropathy; Electro-acupuncture; Taxane.

Conflict of interest statement

Disclaimers: The authors declare that they have no conflicts of interest.

Figures

Figure 1. CONSORT diagram of patient recruitment, randomization and follow-up

Abbreviations: Abbreviations: EA, electro-acupuncture

Figure 2. Measurement of pain and neurotoxicity symptoms at baseline and week 6, 12 and 16

Higher BPI-SF (A) and NPS-4 (B) scores indicate more pain symptoms; whereas higher FACT-NTX (C) and FACT-TAX (D) scores suggest less neurotoxicity. Over the course of receiving taxane chemotherapy, patients reported more pain and neurotoxicity symptoms in general. There was no difference in mean BPI-SF worst pain score (A), NPS-4 score (B), FACT-NTX score (C), and FACT-TAX score between treatment arms during the 12 weeks of chemotherapy. However, the electro-acupuncture (EA) arm reported significantly higher pain (p=0.03) (A) and more neuropathic pain (p=0.03) (B) compared to the sham electro-acupuncture (SEA) arm 4 weeks after chemotherapy was completed (16 weeks).