Overview

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

Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
0
Participant gender:
All
Summary
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment of CIPN in cancer stable patients or patients in remission.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virginia Commonwealth University
Treatments:
Nicotine
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 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