Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

Inclusion Criteria

• •Clinically diagnosed peripheral sensory neuropathy defined as:
• •Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale
• •* Grade 1 Asymptomatic
• •* Grade 2 Moderate symptoms; limiting instrumental activities of daily living (ADL)
• •* Grade 3 Severe symptoms; limiting self-care ADL
• •* Grade 4 Life-threatening consequences; urgent intervention indicated
• •Have a baseline chemotherapy-induced peripheral neuropathy (CIPN) patient reported outcome (PRO) total sensory score ≥ 24.3 on a 19 to 76 scale using the European Organization for Research and Treatment of Cancer Quality of Life-CIPN20 Questionnaire (EORTC QLQ-CIPN-20)
• •Have a CIPN-related neuropathic pain score ≥ 4 on a 0 to 10 scale using the Brief Pain Inventory-Short Form (BPI-SF) item 5
• •Will not have used any nicotine or tobacco products (eg, cigarettes, electronic cigarettes, smokeless tobacco, or other nicotine replacement therapies) within 14 days prior to study treatment start date
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• •Not currently receiving any chemotherapy
• •Have previously received platinum- and/or taxane-based chemotherapy treatments and have persistent pain at least 3 months after completion of treatments.
• •Willing and able to comply with study procedures and visit schedule.
• •Willing to abstain from all tobacco/nicotine product use during study treatment and 30-day follow-up period.
• •Ability to self-apply or have the patch applied at home daily.
• •Ability to understand and the willingness to sign a written informed consent document