study of nicotine for pain associated with chemotherapy-induced peripheral neuropathy

Conditions: Neuropathy; Peripheral Neuropathy; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy

Summary: assess the efficacy of short-term nicotine transdermal patch administration for the treatment of chemotherapy-induced peripheral neuropathy (cipn) in cancer stable patients or patients in remission.

this phase 2 study will test the efficacy of short-term transdermal nicotine transdermal patch administration in patients who have been diagnosed with cipn. the study will follow an open-label, crossover within-subjects clinical trial design with nicotine transdermal patch.

Eligibility criteria:
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 exclusion criteria: * history of pre-existing peripheral sensory neuropathies related to the following: * autoimmune disease * b12/folate deficiency * diabetes mellitus * human immunodeficiency virus (hiv) * hyper/hypothyroidism * monoclonal gammopathy of undetermined significance or multiple myeloma * history of receiving other types of neurotoxic chemotherapy drugs (eg, vinca alkaloids, bortezomib, thalidomide) * current or prior pheochromocytoma * history of or active or clinically significant cardiac disease including any of the following: * unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment * myocardial infarction diagnosed within 6 months prior to initiating study treatment * cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers * new york heart association (nyha) class iii or iv congestive heart failure * poorly controlled high or low blood pressure defined as: * systolic blood pressure (sbp) ≥ 140; diastolic blood pressure (dbp) ≥ 90 * sbp ≤ 90; dbp ≤ 60 * regular use of the following medications: * varenicline * bupropion (ie, bupropion hydrochloride sustained release) * women will be excluded if they are breastfeeding or are pregnant (by urinalysis) within 14 days prior to the start of nicotine transdermal patch administration. * medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Keywords: nicotine peripheral neuropathy