<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468230</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16-12518</org_study_id>
    <nct_id>NCT04468230</nct_id>
  </id_info>
  <brief_title>Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy</brief_title>
  <official_title>Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the efficacy of short-term nicotine transdermal patch administration for the treatment&#xD;
      of CIPN in cancer stable patients or patients in remission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase 2 study will test the efficacy of short-term transdermal nicotine transdermal&#xD;
      patch administration in patients who have been diagnosed with CIPN. The study will follow an&#xD;
      open-label, crossover within-subjects clinical trial design with nicotine transdermal patch.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low Accrual Rate&#xD;
  </why_stopped>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of short-term nicotine transdermal patch administration in the treatment of cancer induced peripheral neuropathy (CIPN)</measure>
    <time_frame>79 Days</time_frame>
    <description>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 European Organization for Research and Treatment of Cancer Quality of Life-cancer induced peripheral neuropathy (CIPN20) Questionnaire (EORTC QLQ-CIPN-20) (eg, an improvement in the patients quality of life by one grade)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of pain-related changes and degree of functional interference in the treatment of CIPN</measure>
    <time_frame>79 Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants at Risk and Affected by Adverse Events (AEs) related to the transdermal nicotine patch.</measure>
    <time_frame>79 Days</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Neuropathy</condition>
  <condition>Peripheral Neuropathy</condition>
  <condition>Neuropathic Pain</condition>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Nicotine Transdermal Patch Administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Transdermal Patch</intervention_name>
    <description>Nicotine Treatment Condition</description>
    <arm_group_label>Nicotine Transdermal Patch Administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed peripheral sensory neuropathy defined as:&#xD;
&#xD;
          -  Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale&#xD;
&#xD;
               -  Grade 1 Asymptomatic&#xD;
&#xD;
               -  Grade 2 Moderate symptoms; limiting instrumental activities of daily living (ADL)&#xD;
&#xD;
               -  Grade 3 Severe symptoms; limiting self-care ADL&#xD;
&#xD;
               -  Grade 4 Life-threatening consequences; urgent intervention indicated&#xD;
&#xD;
          -  Have a baseline CIPN patient reported outcome (PRO) total sensory score ≥ 24.3 on a 19&#xD;
             to 76 scale using the EORTC QLQ-CIPN-20 questionnaire&#xD;
&#xD;
          -  Have a CIPN-related neuropathic pain score ≥ 4 on a 0 to 10 scale using the Brief Pain&#xD;
             Inventory-Short Form (BPI-SF) item 5&#xD;
&#xD;
          -  Will not have used any nicotine or tobacco products (eg, cigarettes, electronic&#xD;
             cigarettes, smokeless tobacco, or other nicotine replacement therapies) within 14 days&#xD;
             prior to study treatment start date&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
&#xD;
          -  Not currently receiving any chemotherapy&#xD;
&#xD;
          -  Have previously received platinum- and/or taxane-based chemotherapy treatments and&#xD;
             have persistent pain at least 3 months after completion of treatments.&#xD;
&#xD;
          -  Willing and able to comply with study procedures and visit schedule.&#xD;
&#xD;
          -  Willing to abstain from all tobacco/nicotine product use during study treatment and&#xD;
             30-day follow-up period.&#xD;
&#xD;
          -  Ability to self-apply or have the patch applied at home daily.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of pre-existing peripheral sensory neuropathies related to the following:&#xD;
&#xD;
               -  Autoimmune disease&#xD;
&#xD;
               -  B12/folate deficiency&#xD;
&#xD;
               -  Diabetes Mellitus&#xD;
&#xD;
               -  Human immunodeficiency virus (HIV)&#xD;
&#xD;
               -  Hyper/hypothyroidism&#xD;
&#xD;
               -  Monoclonal gammopathy of undetermined significance or multiple myeloma&#xD;
&#xD;
          -  History of receiving other types of neurotoxic chemotherapy drugs (eg, vinca&#xD;
             alkaloids, bortezomib, thalidomide)&#xD;
&#xD;
          -  Current or prior pheochromocytoma&#xD;
&#xD;
          -  History of or active or clinically significant cardiac disease including any of the&#xD;
             following:&#xD;
&#xD;
               -  Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months&#xD;
                  prior to initiating study treatment&#xD;
&#xD;
               -  Myocardial infarction diagnosed within 6 months prior to initiating study&#xD;
                  treatment&#xD;
&#xD;
               -  Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers&#xD;
&#xD;
          -  New York Heart Association (NYHA) class III or IV congestive heart failure&#xD;
&#xD;
          -  Poorly controlled high or low blood pressure defined as:&#xD;
&#xD;
               -  Systolic blood pressure (SBP) ≥ 140; Diastolic blood pressure (DBP) ≥ 90&#xD;
&#xD;
               -  SBP ≤ 90; DBP ≤ 60&#xD;
&#xD;
          -  Regular use of the following medications:&#xD;
&#xD;
               -  Varenicline&#xD;
&#xD;
               -  Bupropion (ie, bupropion hydrochloride sustained release)&#xD;
&#xD;
          -  Women will be excluded if they are breastfeeding or are pregnant (by urinalysis)&#xD;
             within 14 days prior to the start of nicotine transdermal patch administration.&#xD;
&#xD;
          -  Medical, psychological, or social condition that, in the opinion of the investigator,&#xD;
             may increase the patient's risk or limit the patient's adherence with study&#xD;
             requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renato Martins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massey Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Community Memorial Healthcenter</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <disposition_first_submitted>July 13, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>August 21, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 29, 2023</disposition_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nicotine</keyword>
  <keyword>Peripheral Neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 1, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468230
org study id: MCC-16-12518
nct id: NCT04468230
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment
      of CIPN in cancer stable patients or patients in remission.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Efficacy of short-term nicotine transdermal patch administration in the treatment of cancer induced peripheral neuropathy (CIPN)
time frame: 79 Days
description: 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 European Organization for Research and Treatment of Cancer Quality of Life-cancer induced peripheral neuropathy (CIPN20) Questionnaire (EORTC QLQ-CIPN-20) (eg, an improvement in the patients quality of life by one grade)
measure: Efficacy of pain-related changes and degree of functional interference in the treatment of CIPN
time frame: 79 Days
description: 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.
measure: Number of Participants at Risk and Affected by Adverse Events (AEs) related to the transdermal nicotine patch.
time frame: 79 Days
description: 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)
arm group label: Nicotine Transdermal Patch Administration
arm group type: Experimental
description: 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).
intervention type: Drug
intervention name: Nicotine Transdermal Patch
description: Nicotine Treatment Condition
arm group label: Nicotine Transdermal Patch Administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renato Martins, MD
role: Principal Investigator
affiliation: Massey Cancer Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Neuralgia
mesh term: Nicotine
sharing ipd: No
submitted: September 1, 2023