Clinical trial NCT04468230: Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Official title: Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuropathy
Peripheral Neuropathy
Neuropathic Pain
Chemotherapy-induced Peripheral Neuropathy
Keywords: Nicotine
Peripheral Neuropathy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)
timeFrame: 79 Days
Secondary outcomes:
measure: Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN
timeFrame: 79 Days
measure: Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.
timeFrame: 79 Days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: VCU Community Memorial Healthcenter
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Renato Martins, MD
role: PRINCIPAL_INVESTIGATOR
References: