Abstract PS1-01-02: Acupuncture for Preventing Progression of Taxane-Induced Peripheral Neuropathy (ATP) Beyond Cryotherapy: A Phase II Randomized, Double-Blinded, Sham-Controlled Trial

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects up to 80% of breast cancer patients treated with neurotoxic chemotherapy, with nearly 50% requiring dose reduction or discontinuation. While cryotherapy has shown promise in CIPN prevention, many patients still develop symptoms. This study evaluated the effectiveness of real versus sham acupuncture in early-stage breast cancer patients who developed CIPN despite using cryotherapy during taxane-based chemotherapy. Method: Chemotherapy included paclitaxel or nab-paclitaxel, with co-administered agents (e.g., carboplatin, pembrolizumab, trastuzumab, pertuzumab) permitted. Patients were randomized in a 1:1 to receive either real acupuncture (RA) or sham acupuncture (SA) weekly for a minimum of four sessions during chemotherapy. The primary outcome was neuropathy pain by the Neuropathic Pain Scale (NPS) after 4 weeks of intervention. Secondary outcomes included the relative dose intensity (RDI) of taxane chemotherapy, defined as the ratio of delivered dose to planned dose. Licensed acupuncturists delivered semi-standardized protocols. All continuous outcomes were analyzed using constrained linear mixed models adjusting for randomization stratification variables; binary RDI was analyzed using logistic regression. Results: Eighty female patients were enrolled (median age, 51.0 years; range, 24.0-80.9). Paclitaxel was used in 75%, nab-paclitaxel in 25%, and cryotherapy in 94.6%. Baseline characteristics were balanced. The retention rate was 28.8%. No acupuncture-related adverse events occurred. After 4 weeks, both RA and SA groups showed statistically significant NPS reductions (RA: -6.07, P = .039; SA: -6.98, P = .021), sustained at 12-week follow-up (RA: -12.68, P < .001; SA: -10.52, P < .001). RDI was 94% in both arms, with >80% maintaining ≥85% RDI (P = .80). Numerically, more RA patients achieved ≥30% NPS reduction (15 vs 11), and fewer worsened (6 vs 11) than SA, though differences were not significant (P = .20). Conclusion: This is the first sham acupuncture-controlled study to evaluate the effectiveness of acupuncture in preventing CIPN progression after cryotherapy in patients with breast cancer. Both RA and SA were associated with statistically significant reductions in neuropathy pain and high chemotherapy delivery. However, the absence of significant differences between real and sham acupuncture suggests that acupuncture may not provide specific therapeutic benefits beyond placebo or attention effects. The continuous improvement observed during and after chemotherapy exceeded the typical trajectory of CIPN, suggesting potential therapeutic effects of both RA and SA warrant further investigation. Citation Format: I. Zhi, E. Kwag, R. Baser, S. Li, L. Taylor, D. Kim, J. Mao, T. Bao. Acupuncture for Preventing Progression of Taxane-Induced Peripheral Neuropathy (ATP) Beyond Cryotherapy: A Phase II Randomized, Double-Blinded, Sham-Controlled Trial [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-01-02.