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

NCT ID: NCT04468230

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2022-05-31

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.

Conditions

Neuropathy; Peripheral Neuropathy; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nicotine Transdermal Patch Administration

Each patient will complete two 14-day treatment conditions, for 7 mg nicotine transdermal patch administration with a washout period in between (≥ 14 days and up to 21 days), then 14 mg nicotine transdermal patch administration (14 days).

Group Type: EXPERIMENTAL

Nicotine Transdermal Patch

Intervention Type: DRUG

Nicotine Treatment Condition

Interventions

Nicotine Transdermal Patch

Nicotine Treatment Condition

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renato Martins, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

VCU Community Memorial Healthcenter

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MCC-16-12518

Identifier Type: -

Identifier Source: org_study_id