<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/NCT03782402</url>
  </required_header>
  <id_info>
    <org_study_id>7635</org_study_id>
    <nct_id>NCT03782402</nct_id>
  </id_info>
  <brief_title>Cannabinoids for Taxane Induced Peripheral Neuropathy</brief_title>
  <official_title>The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</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>
      Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing&#xD;
      breast cancer treatment. Some patients may need to shorten their course of treatment, and do&#xD;
      not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the&#xD;
      cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The&#xD;
      goal of this study is to investigate the cannabinoids THC and CBD for TIPN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for&#xD;
      TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral&#xD;
      neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study&#xD;
      involves the administration of cannabinoids in different strength capsules. The primary&#xD;
      outcome measures include measures of pain and functional impairment (non-painful symptoms).&#xD;
      The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2)&#xD;
      BPI pain interference subscale for functional impairment. The study outcomes will also&#xD;
      include secondary measures of perception, which will be performed in the laboratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding being sought&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory-Short Form (BPI)</measure>
    <time_frame>value at the later time (8 weeks) point minus the value at the earlier time point (baseline)</time_frame>
    <description>This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10</description>
  </primary_outcome>
  <other_outcome>
    <measure>Functional Assessment of Cancer Therapy Taxane</measure>
    <time_frame>Baseline and weekly until end of study.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Cannabinoids (THC and CBD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>THC and CBD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Cannabinoids</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo cannabinoids</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabinoids</intervention_name>
    <description>Cannabinoids with THC and CBD versus placebo cannabinoids</description>
    <arm_group_label>Cannabinoids (THC and CBD)</arm_group_label>
    <arm_group_label>Placebo Cannabinoids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.&#xD;
&#xD;
          -  2) Participants must have an ECOG score of 2 or better. Participants must have a score&#xD;
             of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria&#xD;
             Adverse Events (CTCAE).&#xD;
&#xD;
          -  3) Able to give informed consent and comply with all study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Diagnosis of a major medical, neurological, or psychiatric disorder that would&#xD;
             preclude study participation.&#xD;
&#xD;
          -  2) Women who are not practicing an effective form of birth control (condoms,&#xD;
             diaphragm, birth control pill, IUD) or currently pregnant.&#xD;
&#xD;
          -  3) Subjects taking warfarin.&#xD;
&#xD;
          -  4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or&#xD;
             neurodegenerative disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>1051 Riverside Drive</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>August 2, 2022</results_first_submitted>
  <results_first_submitted_qc>January 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2023</results_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Diana Martinez</investigator_full_name>
    <investigator_title>Psychiatrist II</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03782402/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were assigned based on history of cannabis use.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cannabinoids (THC and CBD)</title>
          <description>Cannabinoids with THC and CBD, titrated to a maximum of 15 mg THC, 300 mg CBD</description>
        </group>
        <group group_id="P2">
          <title>Placebo Cannabinoids</title>
          <description>Placebo cannabinoids for comparison</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cannabinoids (THC and CBD)</title>
          <description>Cannabinoids THC and CBD titrated</description>
        </group>
        <group group_id="B2">
          <title>Placebo Cannabinoids</title>
          <description>placebo cannabinoids for comparison</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" spread="8"/>
                    <measurement group_id="B2" value="54" spread="8"/>
                    <measurement group_id="B3" value="54" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Brief Pain Inventory-Short Form (BPI)</title>
        <description>This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10</description>
        <time_frame>value at the later time (8 weeks) point minus the value at the earlier time point (baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabinoids (THC Ans CBD)</title>
            <description>Cannabinoids with different concentrations of THC and CBD</description>
          </group>
          <group group_id="O2">
            <title>Placebo Cannabinoids</title>
            <description>Placebo with no THC to CBD</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory-Short Form (BPI)</title>
          <description>This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.5"/>
                    <measurement group_id="O2" value="5.8" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Functional Assessment of Cancer Therapy Taxane</title>
        <time_frame>Baseline and weekly until end of study.</time_frame>
        <posting_date>10/2028</posting_date>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Total Neuropathy Score (TNSc) a Scale of Sensory, Motor and Autonomic Symptom</title>
        <time_frame>Baseline and weekly until end of study</time_frame>
        <posting_date>10/2030</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over 8 weeks.</time_frame>
      <desc>No participants were expected to ne at risk for all-cause mortality.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cannabinoids (THC and CBD)</title>
          <description>Strengths of cannabinoids will vary across groups&#xD;
Cannabinoids: Cannabinoids with different concentrations of THC and CBD</description>
        </group>
        <group group_id="E2">
          <title>Placebo Cannabinoids</title>
          <description>Strengths of cannabinoids will vary across groups&#xD;
Cannabinoids: Cannabinoids with different concentrations of THC and CBD</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>SNOMED CT</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Please note: this was a pilot study that was not funded for a full study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Diana Martinez</name_or_title>
      <organization>CUIMC</organization>
      <phone>646-774-6160</phone>
      <email>dm437@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03782402
org study id: 7635
nct id: NCT03782402
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing
      breast cancer treatment. Some patients may need to shorten their course of treatment, and do
      not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the
      cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The
      goal of this study is to investigate the cannabinoids THC and CBD for TIPN.
The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for
      TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral
      neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study
      involves the administration of cannabinoids in different strength capsules. The primary
      outcome measures include measures of pain and functional impairment (non-painful symptoms).
      The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2)
      BPI pain interference subscale for functional impairment. The study outcomes will also
      include secondary measures of perception, which will be performed in the laboratory.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Brief Pain Inventory-Short Form (BPI)
time frame: value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
description: This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10
measure: Functional Assessment of Cancer Therapy Taxane
time frame: Baseline and weekly until end of study.
arm group label: Cannabinoids (THC and CBD)
arm group type: Experimental
description: THC and CBD
arm group label: Placebo Cannabinoids
arm group type: Placebo Comparator
description: placebo cannabinoids
intervention type: Drug
intervention name: Cannabinoids
description: Cannabinoids with THC and CBD versus placebo cannabinoids
arm group label: Cannabinoids (THC and CBD)
arm group label: Placebo Cannabinoids
criteria: 
gender: Female
gender based: Yes
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Diana Martinez
investigator title: Psychiatrist II
mesh term: Peripheral Nervous System Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Please note: this was a pilot study that was not funded for a full study.
point of contact: 