Acupuncture as a modality of treatment for chemotherapy-induced peripheral neuropathy in breast cancer: A phase 3 randomized controlled trial (ABC-CIPN).

12126 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect in early breast cancer (EBC) and is an unmet need. The study aimed to evaluate the efficacy 95% CI, 4.30- 8.10; P<0.0001) in TPS of pain detect scale and improvement (decrease) of about 11.56 (95% CI 4.22-18.91) points Vs 3.27 (95% CI -3.93 to 10.47, P=0.0151, in PSS of EORTC QOL-C-30 scale. Additionally, higher improvement (enhanced) in overall QOL, in the test Vs control arm, -7.143(95% CI -13.95 to -0.331) Vs -0.654 (95% CI -7.33 to 6.023); P=0.0020, was noted at week 8. Using the mixed-model approach over the 6 months (secondary end points), average EORTC QLQ-CIPN20 SS was 29.8 (SE, 2.34) in test Vs 38.2 (SE, 2.3) in control arm difference -8.0 points (95% CI, -14.9 to -1.9; P = 0.0020). Average QoL score was 9.71(SE, 0.729) in test Vs 12.21 (SE, 0.716) in control arm difference 14.3 points (95% CI, 8.2 to 20.5; P = 0.0007) P=0.0001)] P=0.0001)] in test Vs control arm respectively. Conclusions: Early breast cancer women with CIPN after (neo) adjuvant taxane therapy experienced a significant and clinically meaningful improvement in taxane induced CIPN related quality of life as a result of an 8 week acupuncture protocol. The results are potentially practice changing and merits consideration as a new standard of care globally in this unmet need. Clinical trial information: CTRI/2021/01/030480.