Table 1.

Protocol Inclusion and Exclusion Criteria

Inclusion Criteria	Exclusion Criteria
Age ≥ 18 years	Ongoing or <4 weeks since receiving potentially neurotoxic chemotherapy
Life expectancy ≥3 months	Other known causes of peripheral neuropathy before chemotherapy (e.g., diabetes, cervical or lumbar radiculopathy, HIV, amyloidosis, hypothyroidism)
ECOG Performance Status, 0–2	Known brain or spinal metastases
Summary status of their cancer as stable or no evidence of disease for ≥1 month	Use of another investigational pain-directed therapy within 30 days
Peripheral pain for ≥1 month attributed to CIPN	Prior interventional actions for pain control, including celiac plexus blocks and an implanted drug delivery system (such as Medtronic Synchromed Medtronic, Inc., Fridley, MN)
Average daily pain score ≥5 of 10	Any form of medical “metal” device (e.g., pacemakers, defibrillators, vascular clips or stents, cardiac valve, or joint replacements)
Prior treatment (>4 weeks) with paclitaxel or docetaxel, carboplatin, cis-platinum, oxaliplatin, vincristine, vinblastine, vinorelbine, or bortezomib	An adverse reaction to past use of a TENS unit
	Women who were pregnant, nursing, or using active contraceptive
	Active coronary artery disease within last 6 months
	History of seizures
	Skin conditions preventing application of the electrodes
	Any other medical condition at the investigator discretion felt to compromise the study’s objectives

ECOG = Eastern Cooperative Oncology Group; HIV = human immunodeficiency virus.