Effectiveness of alternating magnetic field therapy on quality of life among cancer survivors with chemotherapy-induced peripheral neuropathy: Insights of SMILE study.

Abstract

12034 Background: Chemotherapy-induced peripheral neuropathy (CIPN) reduces patients' quality of life (QoL) due to consistent sensory and motor disturbances. SMILE study investigated the safety and efficacy of an alternating magnetic field therapy device (AT-04) for CIPN. Methods: This was a multicenter, randomized, sham device-controlled, double-blind study. Patients were eligible if they had CIPN symptoms with a pain Numeric Rating Scale score of 4/10 or more, at least 12 weeks after perioperative chemotherapy, and there was no recurrence. Patients were randomly assigned to use AT-04 or a sham device for 84 days. We showed the primary endpoint, the change in pain NRS at day 85, and notable effect sizes of AT-04 in patients whose last chemotherapy was over a year ago for tingling and numbness NRS. Herein, we report one of the secondary endpoints, EORTC QLQ-CIPN20 (CIPN20), asked at baseline and days 15, 29, 57, 85, and 113. Results: Fourteen patients were allocated to each group. At day 85, there were no significant differences in the mean changes of the CIPN20 sensory scale (-5.25 ± 15.4 in AT-04 vs. -5.72 ± 19.5 in sham; p = 0.95, effect size = 0.03), the motor scale (-8.18 ± 16.6 vs. -1.68 ± 10.2; p = 0.28, effect size = 0.47), or the autonomic scale (-1.85 ± 27.5 vs. -1.52 ± 5.0; p = 0.97, effect size = 0.02). However, the CIPN20 motor scales showed a significant decrease in AT-04 at day 29 (-9.82 ± 13.8 vs. -0.74 ± 8.7; p = 0.04, effect size = 0.92) and day 57 (-11.81 ± 10.6 vs. -0.54 ± 6.7; p < 0.01, effect size = 1.26). Furthermore, among patients whose last chemotherapy was completed more than one year earlier (n = 8 in each group), CIPN20 motor scale significantly decreased from day 29 (-12.43 ± 10.3 vs. 2.38 ± 8.9; p < 0.01, effect size = 1.55) to day 85 (-11.76 ± 10.1 vs. -0.07 ± 11.5; p < 0.05, effect size = 1.08), and this effect persisted at day 113 (28 days after the end of the study treatment). Additionally, both sensory and autonomic scales showed improvement (sensory scale, -8.33 ± 13.5 vs. -0 ± 18.4, p = 0.32, effect size = 0.52; autonomic scale, -10.42 ± 23.5 vs. -2.08 ± 5.9, p = 0.35, effect size = 0.49). Conclusions: In patients whose last chemotherapy occurred more than one year prior, mean changes in the CIPN20 scores showed improvement across the sensory, motor, and autonomic scales. Clinical trial information: jRCT2032220295 .