Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

MCC-16-12518

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.

2020-07-31

2022-05-31

2022-05-31

Terminated

Early phase I

4

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2023-11-08