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Status:

TERMINATED

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

Lead Sponsor:

Virginia Commonwealth University

Conditions:

Neuropathy

Peripheral Neuropathy

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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, crosso...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 31 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT04468230

Start Date

July 31 2020

End Date

May 31 2022

Last Update

November 8 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

2

VCU Community Memorial Healthcenter

Richmond, Virginia, United States, 23950