A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN).
Sub-category:
Symptom Management/Supportive Care/Palliative Care
Category:
Patient and Survivor Care
Meeting:
2013 ASCO Annual Meeting
Abstract No:
9635
Citation:
J Clin Oncol 31, 2013 (suppl; abstr 9635)
Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.
Author(s): Toby Christopher Campbell, Amit J Nimunkar, Janet Retseck, Jens C. Eickhoff, Miroslav Backonja, James F. Cleary, Kristine L Kwekkeboom, Thomas Y Yen; University of Wisconsin Carbone Cancer Center, Madison, WI; University of Wisconsin, Madison, WI; University of Wisconsin Hospitals and Clinics, Madison, WI; Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI; University of Wisconsin School of Nursing, Madison, WI; University of Wisconsin Biomedical Engineering, Madison, WI
Abstract Disclosures
Abstract:
Background: CIPN is a debilitating, dose-limiting toxicity. The MC5A is a non-invasive electro-analgesia device delivering “Scrambler Therapy,” which has shown benefit for painful CIPN in uncontrolled studies. No sham-controlled trials of MC5A have been performed. Methods: Eligible patients included adults with neuropathic pain (NP) for > 6 months, pain scores =4/10 numerical rating scale (NRS), and no history of diabetes or other peripheral neuropathies. Patients received up to 10 daily sessions of 50 minutes with either MC5A or a novel active sham device constructed to deliver a just perceptible electrical sensation. Sham output is neither a TENS nor MC5A and is designed to be nontherapeutic. Active and sham treatments were applied to the affected limbs. 14 patients were randomized with no baseline differences. Patients and evaluators were blinded to study arm. Pain was measured before, daily during, after and 3 months post-treatment (verbal NRS). The primary endpoint was change in pain. Secondary endpoints included quantitative neurosensory testing (QST), validated patient-report measures, and cytokines. Results: There were 7 patients in each arm. The table shows changes in pain scores pre- and post-treatment by day and group. There was no difference between arms and no arm x day interaction. There was no significant day or arm effect for the function sub scales. Conclusions: In a small pilot study, MC5A was not significantly different from sham therapy for the primary outcome. The sham is feasible and provides a mechanism for future controlled studies with MC5A. Secondary endpoints, e.g. QST are forthcoming. Clinical trial information: NCT01261780.
NRS change by day and treatmen.
MC5A (n=7) Sham (n=7)
Day N NRS Change SD P value1 N NRS Change SD P value1 P value2
1 7 -0.14 0.38 0.99 7 0.57 0.98 0.31 0.10
2 7 -0.14 0.94 0.81 7 0.43 1.27 0.75 0.46
3 7 0.00 0.00 7 -0.50 1.08 0.34 0.05
4 7 0.00 0.65 0.99 7 0.21 0.39 0.50 0.52
5 7 -0.43 1.27 0.75 7 -0.36 0.48 0.25 0.67
6 7 -0.21 0.39 0.50 6 -0.42 0.38 0.12 0.30
7 7 -0.50 0.76 0.25 5 -0.60 0.55 0.25 0.65
8 5 -0.40 0.55 0.50 5 0.10 0.55 0.99 0.28
9 5 -0.30 0.45 0.50 5 -0.80 0.57 0.12 0.18
10 5 -0.10 0.89 0.99 5 -0.40 0.55 0.50 0.57
1 Within comparison: Wilcoxon Signed Rank Test. 2 Between comparison: Wilcoxon Rank Sum Test.
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