StudyFinder
Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Recruiting
18 years and over
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 CIPN PRO total sensory score ≥ 24.3 on a 19 to 76 scale using the EORTC QLQ-CIPN-20 questionnaire
• 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:
• SBP ≥ 140; 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
Drug: Nicotine Transdermal Patch
Neuropathy, Peripheral Neuropathy, Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy
Nicotine, Peripheral Neuropathy
Cancer Prevention and Control Study Team - masseycpc@vcu.edu
Chen, Zhi-Jian
Phase 2
HM20019616
NCT04468230
See this study on ClinicalTrials.gov