<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/NCT01682499</url>
  </required_header>
  <id_info>
    <org_study_id>IRB/COSA # 079-12</org_study_id>
    <nct_id>NCT01682499</nct_id>
  </id_info>
  <brief_title>Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy</brief_title>
  <official_title>Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg)&#xD;
      infusion for prevention of taxane induced neuropathy in patients with early stage breast&#xD;
      cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles&#xD;
      or every week for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chemotherapy induced peripheral neuropathy (CIPN) is a major dose limiting side effect of&#xD;
      many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of&#xD;
      functional abilities. Calcium and magnesium infusions were shown to decreased the incidence&#xD;
      and intensity of neuropathy symptoms related to oxaliplatin.&#xD;
&#xD;
      There are currently no effective drugs or treatment modalities for the prevention or&#xD;
      treatment of taxane related neuropathy. Given the morbidity of taxane induced neuropathy and&#xD;
      the safety of Ca/Mg infusion, it is reasonable to assess the feasibility of this intervention&#xD;
      in woman with stage I-III breast cancer receiving adjuvant or neo-adjuvant paclitaxel&#xD;
      treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. Calcium&#xD;
      gluconate and magnesium sulfate, 1 g of each agent in 100 ml D5W will be infused over 30&#xD;
      minutes, immediately before and after each dose of paclitaxel. The Ca/Mg infusion will be&#xD;
      given through the same line used for giving chemotherapy.&#xD;
&#xD;
      The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater)&#xD;
      as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion&#xD;
      during paclitaxel chemotherapy and compare it with historical controls. Secondary endpoints&#xD;
      will include other measures of neuropathy and quality of life such as the FACT-Tax score,&#xD;
      taxane-related neuropathy pain as measured by the Brief Pain Inventory-Short Form (BPI-SF),&#xD;
      and measure of cognitive impairment using FACT-cog score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to assess paclitaxel-related neuropathy (grade 2 or greater)</measure>
    <time_frame>2 years</time_frame>
    <description>The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other measures of neuropathy and quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>The secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-TAX score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taxane-related neuropathic pain</measure>
    <time_frame>2 years</time_frame>
    <description>Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of cognitive impairment</measure>
    <time_frame>2 years</time_frame>
    <description>Measurement of cognitive impairment using FACT-Cog score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Paclitaxel-induced Neuropathy</condition>
  <arm_group>
    <arm_group_label>Calcium and Magnesium Infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>calcium gluconate and magnesium sulfate</intervention_name>
    <description>Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel</description>
    <arm_group_label>Calcium and Magnesium Infusion</arm_group_label>
    <other_name>Ca</other_name>
    <other_name>Mg</other_name>
    <other_name>Calcium</other_name>
    <other_name>Magnesium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 21 years&#xD;
&#xD;
          -  History of stage I-III breast cancer&#xD;
&#xD;
          -  Patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week&#xD;
             for 12 weeks or given every two weeks for 4 cycles&#xD;
&#xD;
          -  Serum magnesium level ≤ UNL&#xD;
&#xD;
          -  Serum calcium level ≤ UNL&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x UNL&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing peripheral neuropathy of any grade&#xD;
&#xD;
          -  Current treatment for arrhythmias&#xD;
&#xD;
          -  Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other&#xD;
             neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or&#xD;
             concurrent treatment with other neuropathic chemotherapy agents&#xD;
&#xD;
          -  Current narcotic use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa Shao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Roosevelt Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neuropathy</keyword>
  <keyword>taxane</keyword>
  <keyword>paclitaxel</keyword>
  <keyword>calcium</keyword>
  <keyword>magnesium</keyword>
  <keyword>prevention</keyword>
  <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>Calcium, Dietary</mesh_term>
    <mesh_term>Magnesium Sulfate</mesh_term>
    <mesh_term>Calcium</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/NCT01682499
org study id: IRB/COSA # 079-12
nct id: NCT01682499
lead sponsor: 
collaborator: 
has dmc: Yes
This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg)
      infusion for prevention of taxane induced neuropathy in patients with early stage breast
      cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles
      or every week for 12 weeks.
Chemotherapy induced peripheral neuropathy (CIPN) is a major dose limiting side effect of
      many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of
      functional abilities. Calcium and magnesium infusions were shown to decreased the incidence
      and intensity of neuropathy symptoms related to oxaliplatin.

      There are currently no effective drugs or treatment modalities for the prevention or
      treatment of taxane related neuropathy. Given the morbidity of taxane induced neuropathy and
      the safety of Ca/Mg infusion, it is reasonable to assess the feasibility of this intervention
      in woman with stage I-III breast cancer receiving adjuvant or neo-adjuvant paclitaxel
      treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. Calcium
      gluconate and magnesium sulfate, 1 g of each agent in 100 ml D5W will be infused over 30
      minutes, immediately before and after each dose of paclitaxel. The Ca/Mg infusion will be
      given through the same line used for giving chemotherapy.

      The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater)
      as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion
      during paclitaxel chemotherapy and compare it with historical controls. Secondary endpoints
      will include other measures of neuropathy and quality of life such as the FACT-Tax score,
      taxane-related neuropathy pain as measured by the Brief Pain Inventory-Short Form (BPI-SF),
      and measure of cognitive impairment using FACT-cog score.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: to assess paclitaxel-related neuropathy (grade 2 or greater)
time frame: 2 years
description: The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls
measure: Other measures of neuropathy and quality of life
time frame: 2 years
description: The secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-TAX score
measure: Taxane-related neuropathic pain
time frame: 2 years
description: Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)
measure: Measure of cognitive impairment
time frame: 2 years
description: Measurement of cognitive impairment using FACT-Cog score
arm group label: Calcium and Magnesium Infusion
arm group type: Experimental
intervention type: Drug
intervention name: calcium gluconate and magnesium sulfate
description: Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel
arm group label: Calcium and Magnesium Infusion
other name: Ca
other name: Mg
other name: Calcium
other name: Magnesium
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Theresa Shao, MD
role: Principal Investigator
affiliation: Beth Israel Medical Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Calcium, Dietary
mesh term: Magnesium Sulfate
mesh term: Calcium