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

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ClinicalTrials.gov Identifier: NCT04468230
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment of CIPN in cancer stable patients or patients in remission.

Condition or disease Intervention/treatment Phase
Neuropathy Peripheral Neuropathy Neuropathic Pain Chemotherapy-induced Peripheral Neuropathy Drug: Nicotine Transdermal Patch Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotine Transdermal Patch Administration
Each patient will complete two 14-day treatment conditions, one each for 7 mg and 14 mg nicotine transdermal patch administration with a washout period in between (≥ 14 days and up to 21 days).
Drug: Nicotine Transdermal Patch
Nicotine Treatment Condition




Primary Outcome Measures :
  1. Efficacy of short-term nicotine transdermal patch administration in the treatment of cancer induced peripheral neuropathy (CIPN) [ Time Frame: 79 Days ]
    To assess the efficacy, of the nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission as defined by a ≥ 2.7 point decrease in the total sensory score of the EORTC QLQ-CIPN-20 (eg, an improvement in the patients quality of life by one grade)


Secondary Outcome Measures :
  1. Efficacy of pain-related changes and degree of functional interference in the treatment of CIPN [ Time Frame: 79 Days ]
    To assess the efficacy of short-term nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission by assessing changes in the degree of pain-related functional interference measured by the BPI-SF interference score.

  2. Number of Participants at Risk and Affected by Adverse Events (AEs) related to the transdermal nicotine patch. [ Time Frame: 79 Days ]
    To assess the AEs profile of nicotine transdermal patch administration for the treatment of CIPN in patients whose cancer is stable or in remission. The Adverse events (AEs) are reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version (CTCAE v 5.0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468230


Contacts
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Contact: Cancer Prevention and Control Study Team 804-628-2164 masseycpc@vcu.edu
Contact: Zhi-Jian Chen, MD, PhD zhi-jian.chen@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Cancer Prevention and Control Study Team    804-628-2164    masseycpc@vcu.edu   
Contact: Zhi-Jian Chen, MD, PhD       zhi-jian.chen@vcuhealth.org   
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Zhi-Jian Chen, MD, PhD Massey Cancer Center
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04468230    
Other Study ID Numbers: MCC-16-12518
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Virginia Commonwealth University:
Nicotine
Peripheral Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuralgia
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action