Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Condition: Neuropathy; Peripheral Neuropathy; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuralgia
Intervention: Nicotine Transdermal Patch
Intervention description: Nicotine Treatment Condition
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nicotine; 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.
    

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