<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/NCT03816904</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH3-RNI18/NEUROTAX</org_study_id>
    <secondary_id>2018-A02884-51</secondary_id>
    <nct_id>NCT03816904</nct_id>
  </id_info>
  <brief_title>Involvement of SK3 Calcium Channel in Taxane Neuropathy</brief_title>
  <acronym>NEUROTAX</acronym>
  <official_title>Involvement of SK3 Calcium Channel in Taxane Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients&#xD;
      surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its&#xD;
      pathophysiology is poorly known and probably multifactorial. A possible mechanism would be&#xD;
      mediated by the activation of the SK3 calcium channel: a retrospective study carried out at&#xD;
      the University Hospital of Tours (Carina RUA) found a significant association between the&#xD;
      number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a&#xD;
      taxane neuropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients hospitalized in medical oncology day hospital at the University Hospital of Tours or&#xD;
      CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for&#xD;
      breast or prostate cancer, will be offered the study.&#xD;
&#xD;
      The mode of administration of chemotherapy and the usual follow-up will not be modified by&#xD;
      the protocol The determination of the SK3 status will be made from an additional tube&#xD;
      collected during a collection as part of the treatment at the first arrival in a day hospital&#xD;
      (no more blood tests). Blood sample of 7mL. Shipments and analyzes of samples in Tours in the&#xD;
      pharmacogenetics laboratory under the responsibility of Dr. BARIN-LE GUELLEC.&#xD;
&#xD;
      This study is non-invasive, without impact on the therapeutic management. The result of the&#xD;
      polymorphism of SK3 will not be indicated in the record, so as not to influence the follow-up&#xD;
      of the treatment and to allow an evaluation of the occurrence of peripheral neuropathy in&#xD;
      blindness of the number of repetitions of the CAG triplet of the KCNN3 gene.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Appearance of a neuropathy secondary to taxanes using Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)</measure>
    <time_frame>From baseline and up to 4 months of follow-up</time_frame>
    <description>Evaluation of neuropathy will be performed using non-invasive test, gold standard, Cancer Institute Common Terminology Criteria for Adverse Events&#xD;
Grading (from best to worst) :&#xD;
0 = normal&#xD;
= slight paresthesia, mild weakness (subjective)&#xD;
= moderate paresthesia, moderate weakness (objective)&#xD;
= severe paresthesia with functional disability, severe weakness&#xD;
= paralysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)</measure>
    <time_frame>From baseline and up to 4 months of follow-up</time_frame>
    <description>Evaluation of neuropathy will be performed using non-invasive test, Total neuropathy score clinical&#xD;
Grading (from best to worst) :&#xD;
Sensory symptoms : 0 = none (N), 1 = symptoms limited finger or toes, 2 = Symptoms extend to ankle or wrist, 3 = Symptoms extend to knee or elbow, 4 = Symptoms above knees or elbow or functionally disabling Motor symptoms : 0 = N, 1 = slight difficulty, 2 = moderate difficulty, 3 = require help/assistance, 4 = paralysis Autonomic symptoms : 0 = N, 1 , 2, 3, 4 (number of symptoms) Pin sensibility and vibration sensibility : 0 = normal (n), 1 = reduced in fingers/toes, 2 = reduced to wrist/ankle, 3 = reduced to elbow/knee, 4 = reduced to above elbow/knee Strength : 0 = n, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, 4 = paralysis Deep tendon reflexe : 0 = n, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent, other reduced, 4 = all reflexes absent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of adverses events to taxanes (dysgeusia, myalgia, digestive toxicity tearing, onycholysis.)</measure>
    <time_frame>From baseline and up to 4 months of follow-up</time_frame>
    <description>Each adverse event will be evaluated using CTCAE score grading (from best to worst) :&#xD;
0 : none&#xD;
1 : minimal&#xD;
2 : moderate&#xD;
3 : severe&#xD;
4 : very severe</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">97</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Breast or prostate cancer</arm_group_label>
    <description>Taken blood samples on patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Blood samples before the introduction of chemotherapy</description>
    <arm_group_label>Breast or prostate cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      assay number of CAG triplets composing the KCNN3 gene usual blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in oncology day hospital for their chemotherapy with taxanes&#xD;
        (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Breast Group&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Breast cancer&#xD;
&#xD;
          -  Chemotherapy with paclitaxel or docetaxel&#xD;
&#xD;
          -  Adjuvant or neoadjuvant chemotherapy in localized cancer or first-line treatment in&#xD;
             metastatic cancer&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Prostate Group&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Metastatic prostate cancer&#xD;
&#xD;
          -  Chemotherapy with docetaxel in 1st line&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anteriority or concomitance of another chemotherapy provider of neuropathy (platinum&#xD;
             salts)&#xD;
&#xD;
          -  Another possible cause of neuropathy: diabetes, alcoholism, vitamin B9 / B12&#xD;
             deficiency, neurodegenerative disease, Raynaud's syndrome&#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>Catherine BARBE, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Hospital, Chinon</name>
      <address>
        <city>Chinon</city>
        <zip>37500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Oncology, University Hospital, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</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>
  <!-- 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/NCT03816904
org study id: RIPH3-RNI18/NEUROTAX
secondary id: 2018-A02884-51
nct id: NCT03816904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients
      surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its
      pathophysiology is poorly known and probably multifactorial. A possible mechanism would be
      mediated by the activation of the SK3 calcium channel: a retrospective study carried out at
      the University Hospital of Tours (Carina RUA) found a significant association between the
      number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a
      taxane neuropathy.
Patients hospitalized in medical oncology day hospital at the University Hospital of Tours or
      CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for
      breast or prostate cancer, will be offered the study.

      The mode of administration of chemotherapy and the usual follow-up will not be modified by
      the protocol The determination of the SK3 status will be made from an additional tube
      collected during a collection as part of the treatment at the first arrival in a day hospital
      (no more blood tests). Blood sample of 7mL. Shipments and analyzes of samples in Tours in the
      pharmacogenetics laboratory under the responsibility of Dr. BARIN-LE GUELLEC.

      This study is non-invasive, without impact on the therapeutic management. The result of the
      polymorphism of SK3 will not be indicated in the record, so as not to influence the follow-up
      of the treatment and to allow an evaluation of the occurrence of peripheral neuropathy in
      blindness of the number of repetitions of the CAG triplet of the KCNN3 gene.
observational model: Cohort
time perspective: Prospective
measure: Appearance of a neuropathy secondary to taxanes using Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
time frame: From baseline and up to 4 months of follow-up
description: Evaluation of neuropathy will be performed using non-invasive test, gold standard, Cancer Institute Common Terminology Criteria for Adverse Events
Grading (from best to worst) :
0 = normal
= slight paresthesia, mild weakness (subjective)
= moderate paresthesia, moderate weakness (objective)
= severe paresthesia with functional disability, severe weakness
= paralysis
measure: Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)
time frame: From baseline and up to 4 months of follow-up
description: Evaluation of neuropathy will be performed using non-invasive test, Total neuropathy score clinical
Grading (from best to worst) :
Sensory symptoms : 0 = none (N), 1 = symptoms limited finger or toes, 2 = Symptoms extend to ankle or wrist, 3 = Symptoms extend to knee or elbow, 4 = Symptoms above knees or elbow or functionally disabling Motor symptoms : 0 = N, 1 = slight difficulty, 2 = moderate difficulty, 3 = require help/assistance, 4 = paralysis Autonomic symptoms : 0 = N, 1 , 2, 3, 4 (number of symptoms) Pin sensibility and vibration sensibility : 0 = normal (n), 1 = reduced in fingers/toes, 2 = reduced to wrist/ankle, 3 = reduced to elbow/knee, 4 = reduced to above elbow/knee Strength : 0 = n, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, 4 = paralysis Deep tendon reflexe : 0 = n, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent, other reduced, 4 = all reflexes absent
measure: Occurence of adverses events to taxanes (dysgeusia, myalgia, digestive toxicity tearing, onycholysis.)
time frame: From baseline and up to 4 months of follow-up
description: Each adverse event will be evaluated using CTCAE score grading (from best to worst) :
0 : none
1 : minimal
2 : moderate
3 : severe
4 : very severe
arm group label: Breast or prostate cancer
description: Taken blood samples on patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer
intervention type: Other
intervention name: Blood samples
description: Blood samples before the introduction of chemotherapy
arm group label: Breast or prostate cancer
assay number of CAG triplets composing the KCNN3 gene usual blood sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine BARBE, MD
role: Study Director
affiliation: University Hospital, Tours
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases