Acupuncture as a modality of treatment for chemotherapy-induced peripheral neuropathy in breast cancer: A phase 3 randomized controlled trial (ABC-CIPN).
Authors: Jyoti Bajpai, Venkatesh Kapu, Jasmine Modi, Sushmita Rath, Akash Pawar, Altaf Siddiqui, Sadhana Kannan, Anbarasan Sekar, Sravan Kumar Chintala, Laboni Sarkar, PRABHAT GHANSHYAM BHARGAVA, Seema Gulia, Rajiv Sarin, Shripad Dinanath Banavali, Rajendra A. Badwe, Sudeep Gupta
Journal: Journal of Clinical Oncology (2024)

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 &amp; safety, of acupuncture on CIPN. Methods: We conducted a prospective, single-center, open-label, phase 3 randomized controlled trial at a tertiary care Indian center. EBC, ≥18 years with ≥grade (gr) 1 CIPN after paclitaxel chemotherapy were block randomized (1:1), &amp; stratified by age (≥/&lt;60 years), to Test (Acupuncture with usual care including pregabalin 75 mg &amp; duloxetine 30 mg, both twice a day per orally, for 4 weeks) &amp; control arm (Usual care alone). Acupuncture was delivered for 12 sessions in gr 1 &amp; 18 sessions in ≥2 CIPN. The primary endpoint was to assess the efficacy of acupuncture in improving QOL as assessed by the sensory score (SS) of QLQ-CIPN20, Pain symptom score (PSS) of QLQ-C30, and total pain score (TPS) by Pain detect scale, and overall QoL by QLQ-C30 at 8 weeks in comparison to baseline (CTRI/2021/01/030480). Results: The median (IQR) age was 50 (43-57) years. Women in test arm in comparison to the control had a significantly higher improvement (decrease) of 26.23 (95% CI 18.52-33.93) versus (Vs) 6.32 (95% CI -1.23 to 13.87) points respectively in CIPN SS at week 8 compared to baseline(least-squares mean difference (LSMD), 19.90 points (95%CI, 11.80-28, P&lt;0.0001). Similarly, patients in test arm had a higher improvement (decrease) of 7.31 (95% CI 5.47-9.13) points Vs 1.12 (95% CI -0.67-2.91) points (LSMD, 6.20 points; 95% CI, 4.30- 8.10; P&lt;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)] &amp; average TPS (pain detect) was 18.0 (SE, 2.72) Vs 18.3 (SE, 2.67) [difference -2.5 points (95% CI, -4.5 to -0.5; P=0.0001)] &amp; PSS ( QLQ-C30 scale) was 29.4 (SE, 2.45) Vs 37.2 (SE, 2.41) [ difference -7.8 points (95% CI, -14.6 to -0.9; 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.