1. Pilot Trial of a Patient-Specific Cutaneous Electrostimulation Device (MC5-A Calmare®) for Chemotherapy-Induced Peripheral Neuropathy
- Author
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G. L. Parker, Viswanathan Ramakrishnan, Thomas J. Smith, Patrick J. Coyne, and Patricia Dodson
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Antineoplastic Agents ,Pilot Projects ,Context (language use) ,Article ,Bortezomib ,Scrambler therapy ,Internal medicine ,medicine ,Humans ,General Nursing ,Aged ,Pain Measurement ,Chemotherapy ,business.industry ,Pilot trial ,Peripheral Nervous System Diseases ,Patient specific ,Middle Aged ,medicine.disease ,Boronic Acids ,Surgery ,Clinical trial ,Treatment Outcome ,Anesthesiology and Pain Medicine ,Peripheral neuropathy ,Oncology ,Chemotherapy-induced peripheral neuropathy ,Pyrazines ,Anesthesia ,Transcutaneous Electric Nerve Stimulation ,Female ,Taxoids ,Neurology (clinical) ,Cancer pain ,business ,medicine.drug - Abstract
Context. Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting and persistent consequence of numerous classes of antineoplastic agents, affecting up to 30%e40% of patients. To date, there is no effective prevention or therapy. An evolving hypothesis for reducing CIPN pain involves direct nerve stimulation to reduce the pain impulse. Objectives. To evaluate the impact on CIPN associated with the MC5-A Calmare therapy device (Competitive Technologies, Inc. Fairfield, CT). Methods. The MC5-A Calmare therapy device is designed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity. Sixteen patients from one center received one-hour interventions daily over 10 working days. Results. Of 18 patients, 16 were evaluable. The mean age of the patients was 58.6 yearsdfour men and 14 womendand the duration of CIPN was three months to eight years. The most common drugs were taxanes, platinums, and bortezomib (Velcade, Millenium Pharmaceuticals, Cambridge MA). At the end of the study (Day 10), a 20% reduction in numeric pain scores was achieved in 15 of 16 patients. The pain score fell 59% from 5.81 � 1.11 before treatment to 2.38 � 1.82 at the end of 10 days (P < 0.0001 by paired t-test). A daily treatment benefit was seen with a strong statistically significant difference between the preand post-daily pain scores (P < 0.001). Four patients had their CIPN reduced to zero. A repeated-measures analysis using the scores from all 10 days confirmed these results. No toxicity was seen. Some responses have been durable without maintenance. Conclusions. Patient-specific cutaneous electrostimulation with the MC5-A Calmare device appears to dramatically reduce pain in refractory CIPN patients with no toxicity. Further studies are underway to define the benefit, mechanisms of action, and optimal schedule. J Pain Symptom Manage 2010;-:-e-. 2010 Published by Elsevier Inc on behalf of U.S. Cancer Pain Relief Committee.
- Published
- 2010