Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare) for chemotherapy-induced peripheral neuropathy.

Abstract

9029 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting and persistent consequence of numerous classes of antineoplastic agents affecting up to 30-40% of patients (pts). To date, there is no highly effective prevention or therapy. An evolving hypothesis for reducing CIPN pain involves direct nerve stimulation to reduce the pain impulse. Methods: We evaluated the effect of the MC5-A Calmare therapy device on CIPN. The device is designed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity. Gel electrodes like EKG pads are applied below and above the dermatomes of pain. Pts with stable CIPN of > 5 pain, off chemotherapy, from one center received 1-hour interventions daily over 10 working days. NCT00952848. Results: The 16 pts had a mean age of 58.6 years; 4 men, 14 women; duration of CIPN all > 3 months up to 8 years. The most common drugs related to their neuropathy were taxanes, platinums, and bortezimib. The primary goal of a 20% in numeric pain scores after day 10 was achieved in 15 of 16. The primary endpoint of CIPN pain score fell by 59% from day 1 to day 10. Adjusting for the correlations and the variability between patients and daily scores with a repeated measures analysis, there was an overall 64% reduction in pain. A daily treatment benefit was seen with a significant difference between the pre and post daily scores. Four patients had their CIPN reduced to 0. No toxicity was seen. Some responses have been durable without maintenance, and some patients had return of normal sensation and motor function. Conclusions: Patient-specific cutaneous electrostimulationwith theMC5-A Calmare device appears to dramatically reduce pain in refractory CIPN patients with no toxicity. Further studies are underway to define the mechanisms of action, duration of benefit, and optimal schedule. Before After P value Reduction in pain by 20% 0 15 of 16 (94%) <0.0001, Fischer's exact test CIPN pain score 5.81 ± 1.11 2.38 ± 1.82-59% <0.0001, paired t test Adjusted pain scores 4.9 ± 0.4 1.8 ± 0.4-64% < 0.0001, repeated measures analysis Daily reduction in pain scores 3.74 ± 0.38 2.72 ± 0.38-1.02, -27% < 0.001, repeated measures analysis No significant financial relationships to disclose.