<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/NCT02970526</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0290</org_study_id>
    <nct_id>NCT02970526</nct_id>
  </id_info>
  <brief_title>Long Term Effect of Oxaliplatin Treatment in Cancer Survivors</brief_title>
  <acronym>PREVOX</acronym>
  <official_title>Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered&#xD;
      the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These&#xD;
      neuropathies remain a problem in oncology because currently no prevention strategy has proved&#xD;
      effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In&#xD;
      the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the&#xD;
      chemotherapy, potentially degrading the oncological prognosis.&#xD;
&#xD;
      Objective of this study will be to assess, on a large number of patients (n&gt; 500) who&#xD;
      completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5&#xD;
      years after the end of chemotherapy. Furthermore, this study should enable an assessment of&#xD;
      the relationship between the intensity of neuropathy and comorbidities, such as anxiety and&#xD;
      depression and health related quality of life of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxaliplatin remains the reference treatment of advanced colorectal cancer and more broadly of&#xD;
      digestive cancers, incorporated in the FOLFOX protocol (folinic acid, 5-Fu, Oxaliplatin). But&#xD;
      oxaliplatin chemotherapy is certainly the most neurotoxic, as on average 90% of patients&#xD;
      develop acute neuropathic disorders (within hours or days of the infusion) and 30% to 50% of&#xD;
      patients develop a chronic neuropathy with repeated cycles of chemotherapy. The neuropathic&#xD;
      grade and duration of symptoms remain variable across studies. Although symptoms improve with&#xD;
      time, long-term studies suggest a persistent neuropathy beyond 24 months. Moreover,&#xD;
      Vatandoust and colleagues suggest that chemotherapy-induced neuropathy is more frequent and&#xD;
      severe over the long term (≥ 12 months) than in previous works published.&#xD;
&#xD;
      In cancer survivors, neuropathy induced by oxaliplatin has a deleterious impact on their&#xD;
      quality of life. But, few studies are available on the consequences of oxaliplatin-induced&#xD;
      neuropathy in these patients, while these patients remain, in 2003, the third largest group&#xD;
      of cancer survivors.&#xD;
&#xD;
      Only 7 studies have specifically evaluated neuropathic disorders induced by oxaliplatin after&#xD;
      chemotherapy. Moreover, as pointed Vatandoust and colleagues, there is a real need to&#xD;
      understand the long term effects of this chemotherapy-induced neuropathy. More specifically,&#xD;
      only two studies have evaluated the effects of neuropathy on quality of life and&#xD;
      comorbidities of patients.&#xD;
&#xD;
      Objective of this study will be to assess, on a large number of patients (n&gt; 500) who&#xD;
      completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5&#xD;
      years after the end of chemotherapy. Furthermore, this study should enable an assessment of&#xD;
      the relationship between the intensity of neuropathy and comorbidities, such as anxiety and&#xD;
      depression and health related quality of life of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">August 29, 2019</completion_date>
  <primary_completion_date type="Actual">August 29, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thermal hypersensitivity to cold and hot assessed by VAS.</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic pain evaluated by the DN4 interview questionnaire.</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression assessed by HADS questionnaire.</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of neuropathy during chemotherapy (NCI-CTCAE).</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain assessed by visual analog scale (VAS).</measure>
    <time_frame>once and until 5 years after the end of chemotherapy</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">409</enrollment>
  <condition>Colorectal Cancer Survivors</condition>
  <condition>Oxaliplatin Regimen</condition>
  <condition>Adult</condition>
  <arm_group>
    <arm_group_label>colorectal cancer survivors</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).</description>
    <arm_group_label>colorectal cancer survivors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        colorectal cancer survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Living patient who received adjuvant chemotherapy (FOLFOX).&#xD;
&#xD;
               -  Patient in remission.&#xD;
&#xD;
               -  FOLFOX chemotherapy over for 0-5 years.&#xD;
&#xD;
               -  Oral Non-opposition to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patient unable to understand or respond to questionnaires.&#xD;
&#xD;
               -  Age &lt;18 years.&#xD;
&#xD;
               -  Neurological diseases (eg Parkinson's disease, stroke, fibromyalgia ...).&#xD;
&#xD;
               -  Legal incapacity (person deprived of liberty or under guardianship).&#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>Denis PEZET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Selvy M, Pereira B, Kerckhove N, Gonneau C, Feydel G, Petorin C, Vimal-Baguet A, Melnikov S, Kullab S, Hebbar M, Bouche O, Slimano F, Bourgeois V, Lebrun-Ly V, Thuillier F, Mazard T, Tavan D, Benmammar KE, Monange B, Ramdani M, Pere-Verge D, Huet-Penz F, Bedjaoui A, Genty F, Leyronnas C, Busserolles J, Trevis S, Pinon V, Pezet D, Balayssac D. Long-Term Prevalence of Sensory Chemotherapy-Induced Peripheral Neuropathy for 5 Years after Adjuvant FOLFOX Chemotherapy to Treat Colorectal Cancer: A Multicenter Cross-Sectional Study. J Clin Med. 2020 Jul 27;9(8):2400. doi: 10.3390/jcm9082400.</citation>
    <PMID>32727095</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal cancer survivors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxaliplatin</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/NCT02970526
org study id: CHU-0290
nct id: NCT02970526
lead sponsor: 
This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered
      the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These
      neuropathies remain a problem in oncology because currently no prevention strategy has proved
      effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In
      the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the
      chemotherapy, potentially degrading the oncological prognosis.

      Objective of this study will be to assess, on a large number of patients (n> 500) who
      completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5
      years after the end of chemotherapy. Furthermore, this study should enable an assessment of
      the relationship between the intensity of neuropathy and comorbidities, such as anxiety and
      depression and health related quality of life of patients.
Oxaliplatin remains the reference treatment of advanced colorectal cancer and more broadly of
      digestive cancers, incorporated in the FOLFOX protocol (folinic acid, 5-Fu, Oxaliplatin). But
      oxaliplatin chemotherapy is certainly the most neurotoxic, as on average 90% of patients
      develop acute neuropathic disorders (within hours or days of the infusion) and 30% to 50% of
      patients develop a chronic neuropathy with repeated cycles of chemotherapy. The neuropathic
      grade and duration of symptoms remain variable across studies. Although symptoms improve with
      time, long-term studies suggest a persistent neuropathy beyond 24 months. Moreover,
      Vatandoust and colleagues suggest that chemotherapy-induced neuropathy is more frequent and
      severe over the long term (≥ 12 months) than in previous works published.

      In cancer survivors, neuropathy induced by oxaliplatin has a deleterious impact on their
      quality of life. But, few studies are available on the consequences of oxaliplatin-induced
      neuropathy in these patients, while these patients remain, in 2003, the third largest group
      of cancer survivors.

      Only 7 studies have specifically evaluated neuropathic disorders induced by oxaliplatin after
      chemotherapy. Moreover, as pointed Vatandoust and colleagues, there is a real need to
      understand the long term effects of this chemotherapy-induced neuropathy. More specifically,
      only two studies have evaluated the effects of neuropathy on quality of life and
      comorbidities of patients.

      Objective of this study will be to assess, on a large number of patients (n> 500) who
      completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5
      years after the end of chemotherapy. Furthermore, this study should enable an assessment of
      the relationship between the intensity of neuropathy and comorbidities, such as anxiety and
      depression and health related quality of life of patients.
observational model: Other
time perspective: Cross-Sectional
measure: Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
time frame: once and until 5 years after the end of chemotherapy
measure: Thermal hypersensitivity to cold and hot assessed by VAS.
time frame: once and until 5 years after the end of chemotherapy
measure: Neuropathic pain evaluated by the DN4 interview questionnaire.
time frame: once and until 5 years after the end of chemotherapy
measure: Anxiety and depression assessed by HADS questionnaire.
time frame: once and until 5 years after the end of chemotherapy
measure: Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).
time frame: once and until 5 years after the end of chemotherapy
measure: Grade of neuropathy during chemotherapy (NCI-CTCAE).
time frame: once and until 5 years after the end of chemotherapy
measure: Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin
time frame: once and until 5 years after the end of chemotherapy
measure: pain assessed by visual analog scale (VAS).
time frame: once and until 5 years after the end of chemotherapy
arm group label: colorectal cancer survivors
intervention type: Drug
intervention name: Oxaliplatin
description: Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
arm group label: colorectal cancer survivors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Denis PEZET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
citation: Selvy M, Pereira B, Kerckhove N, Gonneau C, Feydel G, Petorin C, Vimal-Baguet A, Melnikov S, Kullab S, Hebbar M, Bouche O, Slimano F, Bourgeois V, Lebrun-Ly V, Thuillier F, Mazard T, Tavan D, Benmammar KE, Monange B, Ramdani M, Pere-Verge D, Huet-Penz F, Bedjaoui A, Genty F, Leyronnas C, Busserolles J, Trevis S, Pinon V, Pezet D, Balayssac D. Long-Term Prevalence of Sensory Chemotherapy-Induced Peripheral Neuropathy for 5 Years after Adjuvant FOLFOX Chemotherapy to Treat Colorectal Cancer: A Multicenter Cross-Sectional Study. J Clin Med. 2020 Jul 27;9(8):2400. doi: 10.3390/jcm9082400.
PMID: 32727095
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Oxaliplatin