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

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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 & 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), & stratified by age (≥/<60 years), to Test (Acupuncture with usual care including pregabalin 75 mg & duloxetine 30 mg, both twice a day per orally, for 4 weeks) & control arm (Usual care alone). Acupuncture was delivered for 12 sessions in gr 1 & 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<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<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)] & 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)] & 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.