<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/NCT03812523</url>
  </required_header>
  <id_info>
    <org_study_id>SA2018005 LVD</org_study_id>
    <nct_id>NCT03812523</nct_id>
  </id_info>
  <brief_title>Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy</brief_title>
  <official_title>A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeastern Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeastern Regional Medical Center</source>
  <oversight_info>
    <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>
      A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of&#xD;
      Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To examine lorcaserin a selective R-HT2c receptor antagonist approved by FDA as weight loss&#xD;
      drug- for its ability to improve proprioceptive movements in patients with advanced&#xD;
      colorectal cancer who developed neurotoxicity during oxaliplatin-based chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a two-arm randomized controlled clinical trial in cancer patients receiving oxaliplatin treatment reporting neurotoxicity Grade 2 or higher by CTCAE guidelines to a member of their medical team. Enrollment goal is 50 patients. (25 evaluable patients per arm)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Coded Bottles</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.</measure>
    <time_frame>180 days</time_frame>
    <description>Duloxetine efficacy as Measured by Pain Score 0-10 Numerical Rating Scale. Subject will rate level of pain experienced from 0 (No Pain) to 10 (Worst Possible Pain) for each question on the Brief Pain Inventory Short Form. A rating of 5 would be Moderate Pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.</measure>
    <time_frame>180 days</time_frame>
    <description>Subject quality of life will be measured using the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxocity (FACT/GOG-NTX) Questionnaire. For each statement, the subject will answer 0-5 with 0 being &quot;Not at All&quot; and 5 being &quot;Very Much&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.</measure>
    <time_frame>180 days</time_frame>
    <description>Subject quality of life will also be measured using the MD Anderson Symptom Inventory (MDASI) Questionnaire, with CTCA addendum. For each statement, the subject will answer from 0-10, with 0 being &quot;Not Present&quot; and 10 being &quot;As Bad as You Can Imagine)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chemotherapy-Induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Duloxetine 60 mg qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lorcaserin 10 mg bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine 60 mg qd</intervention_name>
    <description>60 mg tablet Taken by mouth, Once Daily for 180 Days</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorcaserin</intervention_name>
    <description>10 mg tablet Taken by mouth Twice Daily for 180 Days</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a diagnosis of invasive colorectal cancer, locally advanced or advanced,&#xD;
             requiring oxaliplatin-based chemotherapy for treatment.&#xD;
&#xD;
          -  Subject has agreed to receive treatment at Cancer Treatment Centers of America,&#xD;
             Southeastern Regional Medical Center.&#xD;
&#xD;
          -  Subject is Male or Female&#xD;
&#xD;
          -  Subject is 18 years of age or older.&#xD;
&#xD;
          -  Subject is a patient who reports neurotoxicity symptom grade 2 or more according CTCAE&#xD;
             criteria to his or her medical oncologist following one or more cycles of&#xD;
             oxaliplatin-based chemotherapy treatment.&#xD;
&#xD;
          -  Subject is a patient who is capable and accepting of completing study questionnaires&#xD;
             at each data collection point.&#xD;
&#xD;
          -  Subject has adequate English fluency for completion of data collection. The surveys&#xD;
             were designed and validated in English and are not currently available in other&#xD;
             languages. Translation of questionnaires into other languages would require&#xD;
             reestablishing the reliability and validity of these measures. Therefore, participants&#xD;
             must be able to communicate in English to complete the surveys.&#xD;
&#xD;
          -  Subject must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
          -  Subject must be willing to comply with all study procedures and be available for the&#xD;
             duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have previously been exposed to neurotoxic agents including pyridoxine&#xD;
             (&gt;100 mg/day), colchicine, allopurinol, or phenytoin;&#xD;
&#xD;
          -  Subjects with pre-existing comorbidities, such as: diabetes, uremia, significant&#xD;
             peripheral vascular disease, HIV, or progressive or degenerative neurologic disorders&#xD;
             (e.g., multiple sclerosis, B12 deficiency); cardiovascular valve disease, history of&#xD;
             cardiovascular event,&#xD;
&#xD;
          -  Subjects with a history of lumbosacral laminectomy or radiculopathy;&#xD;
&#xD;
          -  Subjects who have been prescribed and taken gabapentin, pregabalin, or duloxetine&#xD;
             currently or within the last 1 months)&#xD;
&#xD;
          -  Subjects who have established or suspected family history of inherited neuropathy.&#xD;
&#xD;
          -  Subjects unable to swallow indicated medication&#xD;
&#xD;
          -  Subjects in general with a medical condition, laboratory finding, or physical exam&#xD;
             finding that precludes participation&#xD;
&#xD;
          -  Subject weight of ≥350 lbs.&#xD;
&#xD;
          -  Subjects who currently use disallowed concomitant medications&#xD;
&#xD;
          -  Subjects with any form of cardiac implants&#xD;
&#xD;
          -  Subjects who report recent febrile illness that precludes or delays participation&#xD;
&#xD;
          -  Subjects with pregnancy or lactation&#xD;
&#xD;
          -  Subjects with known allergic reactions to components of the study product(s)&#xD;
&#xD;
          -  Subjects receiving treatment with another investigational drug or other intervention&#xD;
&#xD;
          -  Subjects with a history of or current tobacco or illegal substance use&#xD;
&#xD;
          -  Subjects exhibiting significant psychiatric or cognitive impairment&#xD;
             (dementia/delirium, retardation, active psychosis) that in the judgment of the&#xD;
             investigators would preclude providing informed consent and study participation.&#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_contact>
    <last_name>Nathan Neufeld, DO</last_name>
    <phone>770-400-6035</phone>
    <email>nathan.neufeld@ctca-hope.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ricardo Alvarez, MD</last_name>
    <phone>770-400-6633</phone>
    <email>ricardo.alvarez@ctca-hope.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America - Atlanta</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Karen Rados</last_name>
      <phone>770-400-6629</phone>
      <email>karen.rados@ctca-hope.com</email>
    </contact>
    <investigator>
      <last_name>Nathan Neufeld, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03812523
org study id: SA2018005 LVD
nct id: NCT03812523
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of
      Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
To examine lorcaserin a selective R-HT2c receptor antagonist approved by FDA as weight loss
      drug- for its ability to improve proprioceptive movements in patients with advanced
      colorectal cancer who developed neurotoxicity during oxaliplatin-based chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a two-arm randomized controlled clinical trial in cancer patients receiving oxaliplatin treatment reporting neurotoxicity Grade 2 or higher by CTCAE guidelines to a member of their medical team. Enrollment goal is 50 patients. (25 evaluable patients per arm)
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Coded Bottles
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the Pain Numerical Rating Scale.
time frame: 180 days
description: Duloxetine efficacy as Measured by Pain Score 0-10 Numerical Rating Scale. Subject will rate level of pain experienced from 0 (No Pain) to 10 (Worst Possible Pain) for each question on the Brief Pain Inventory Short Form. A rating of 5 would be Moderate Pain.
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.
time frame: 180 days
description: Subject quality of life will be measured using the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxocity (FACT/GOG-NTX) Questionnaire. For each statement, the subject will answer 0-5 with 0 being "Not at All" and 5 being "Very Much"
measure: Assessment with respect to duloxetine of the effect of lorcaserin on the patient-reported quality of life.
time frame: 180 days
description: Subject quality of life will also be measured using the MD Anderson Symptom Inventory (MDASI) Questionnaire, with CTCA addendum. For each statement, the subject will answer from 0-10, with 0 being "Not Present" and 10 being "As Bad as You Can Imagine)
arm group label: Control
arm group type: Active Comparator
description: Duloxetine 60 mg qd
arm group label: Intervention
arm group type: Experimental
description: Lorcaserin 10 mg bid
intervention type: Drug
intervention name: Duloxetine 60 mg qd
description: 60 mg tablet Taken by mouth, Once Daily for 180 Days
arm group label: Control
intervention type: Drug
intervention name: Lorcaserin
description: 10 mg tablet Taken by mouth Twice Daily for 180 Days
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Neufeld, DO
phone: 770-400-6035
email: nathan.neufeld@ctca-hope.com
last name: Ricardo Alvarez, MD
phone: 770-400-6633
email: ricardo.alvarez@ctca-hope.com
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Duloxetine Hydrochloride