<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/NCT03840213</url>
  </required_header>
  <id_info>
    <org_study_id>2019-0101SP</org_study_id>
    <secondary_id>2019-A00093-54</secondary_id>
    <nct_id>NCT03840213</nct_id>
  </id_info>
  <brief_title>Nutrition and Chemotherapy</brief_title>
  <acronym>JEUNETCHIMIO</acronym>
  <official_title>Nutrition and Chemotherapy, Representation and Practice in a Cancer Care Centre (JEUNETCHIMIO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ligue contre le cancer, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Cancérologie de la Loire</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>
      Patients treated for cancer nowadays have many means of information and tend to become more&#xD;
      and more involved in their health. The interest of a therapeutic fast with detoxifying or&#xD;
      even curative properties, with a specific indication for cancer patients treated by&#xD;
      chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on&#xD;
      the scope of this information in cancer patients or on the attitudes of oncologists towards&#xD;
      this practice and possible positioning requests from patients.&#xD;
&#xD;
      We hypothesize that the choice of this practice and its modalities are rarely discussed with&#xD;
      oncologists, although it may have deleterious repercussions on the patient's health.&#xD;
&#xD;
      We propose a research based on the principles of sociological intervention. Its objectives&#xD;
      are a first review of the issue and the establishment of a joint working group, including&#xD;
      patients, carers and researchers, which will propose solutions to improve the patient/carer&#xD;
      dialogue on this issue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients treated for cancer nowadays have many means of information and tend to become more&#xD;
      and more involved in their health. The interest of a therapeutic fast with detoxifying or&#xD;
      even curative properties, with a specific indication for cancer patients treated by&#xD;
      chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on&#xD;
      the scope of this information in cancer patients or on the attitudes of oncologists towards&#xD;
      this practice and possible positioning requests from patients.&#xD;
&#xD;
      We hypothesize that the choice of this practice and its modalities are rarely discussed with&#xD;
      oncologists, although it may have deleterious repercussions on the patient's health.&#xD;
&#xD;
      We propose a research based on the principles of sociological intervention. Its objectives&#xD;
      are a first review of the issue and the establishment of a joint working group, including&#xD;
      patients, carers and researchers, which will propose solutions to improve the patient/carer&#xD;
      dialogue on this issue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Number of patients who voluntarily changed their eating habits</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients who voluntarily changed their eating habits will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using complementary or alternative medicines</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients using complementary or alternative medicines will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients discussing these different practices with their oncologist</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients discussing these different practices with their oncologist will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients discussing these different practices with other caregivers</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients discussing these different practices with other caregivers will be reported</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patients undergoing chemotherapy treatment</arm_group_label>
    <description>Patients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Filling a questionnaire and interviewDescription</intervention_name>
    <description>The questionnaire focuses on the dietary practices of patients treated with chemotherapy. It consists of 35 questions, completing an average of 20 minutes.&#xD;
Interviews will be conducted with patients who have changed their diet since the beginning of their treatment in order to further develop the results of the quantitative survey.</description>
    <arm_group_label>Patients undergoing chemotherapy treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who intend to practice, or who practice a form of fasting during their&#xD;
        chemotherapy treatment will be proposed to participate to a qualitative study to collect&#xD;
        more information about their fasting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients, follow-up on Institut de Cancerology Lucien Neuwirth day service&#xD;
             chemotherapy treatment&#xD;
&#xD;
          -  Patient affiliated or entitled to a social security scheme&#xD;
&#xD;
          -  Patient who received informed information about the study&#xD;
&#xD;
          -  Patient able to read French&#xD;
&#xD;
        Patients participating in the qualitative study:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate, protected adult person, under guardianship or curatorship&#xD;
&#xD;
          -  Person unable to understand the conduct of the study&#xD;
&#xD;
          -  Person with a documented history of cognitive or psychiatric disorders&#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>Pierre Fournel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie Lucien Neuwirth</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre Fournel, MD</last_name>
    <phone>04 77 91 70 00</phone>
    <phone_ext>+33</phone_ext>
    <email>pierre.fournel@icloire.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Véronique Régnier-Denois</last_name>
    <phone>04 77 91 74 75</phone>
    <phone_ext>+33</phone_ext>
    <email>veronique.regnier@icloire.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Véronique Régnier-Denois</last_name>
      <phone>04.77.91.74.75</phone>
      <phone_ext>+33</phone_ext>
      <email>veronique.regnier@icloire.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre Fournel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Philippe Jacquin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier Collard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aline Guillot, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Léa Saban-Roche, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thierry Muron, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain Rivoirard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benoîte Mery, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile Vassal, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>nutrition</keyword>
  <keyword>self-care</keyword>
  <keyword>care/caregiver relationship</keyword>
  <keyword>fasting</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03840213
org study id: 2019-0101SP
secondary id: 2019-A00093-54
nct id: NCT03840213
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients treated for cancer nowadays have many means of information and tend to become more
      and more involved in their health. The interest of a therapeutic fast with detoxifying or
      even curative properties, with a specific indication for cancer patients treated by
      chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on
      the scope of this information in cancer patients or on the attitudes of oncologists towards
      this practice and possible positioning requests from patients.

      We hypothesize that the choice of this practice and its modalities are rarely discussed with
      oncologists, although it may have deleterious repercussions on the patient's health.

      We propose a research based on the principles of sociological intervention. Its objectives
      are a first review of the issue and the establishment of a joint working group, including
      patients, carers and researchers, which will propose solutions to improve the patient/carer
      dialogue on this issue.
Patients treated for cancer nowadays have many means of information and tend to become more
      and more involved in their health. The interest of a therapeutic fast with detoxifying or
      even curative properties, with a specific indication for cancer patients treated by
      chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on
      the scope of this information in cancer patients or on the attitudes of oncologists towards
      this practice and possible positioning requests from patients.

      We hypothesize that the choice of this practice and its modalities are rarely discussed with
      oncologists, although it may have deleterious repercussions on the patient's health.

      We propose a research based on the principles of sociological intervention. Its objectives
      are a first review of the issue and the establishment of a joint working group, including
      patients, carers and researchers, which will propose solutions to improve the patient/carer
      dialogue on this issue.
observational model: Cohort
time perspective: Prospective
measure: Number of patients who voluntarily changed their eating habits
time frame: 1 year
description: Number of patients who voluntarily changed their eating habits will be reported
measure: Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment
time frame: 1 year
description: Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment will be reported
measure: Number of patients using complementary or alternative medicines
time frame: 1 year
description: Number of patients using complementary or alternative medicines will be reported
measure: Number of patients discussing these different practices with their oncologist
time frame: 1 year
description: Number of patients discussing these different practices with their oncologist will be reported
measure: Number of patients discussing these different practices with other caregivers
time frame: 1 year
description: Number of patients discussing these different practices with other caregivers will be reported
arm group label: Patients undergoing chemotherapy treatment
description: Patients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment
intervention type: Behavioral
intervention name: Filling a questionnaire and interviewDescription
description: The questionnaire focuses on the dietary practices of patients treated with chemotherapy. It consists of 35 questions, completing an average of 20 minutes.
Interviews will be conducted with patients who have changed their diet since the beginning of their treatment in order to further develop the results of the quantitative survey.
arm group label: Patients undergoing chemotherapy treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Fournel, MD
role: Principal Investigator
affiliation: Institut de Cancérologie Lucien Neuwirth
last name: Pierre Fournel, MD
phone: 04 77 91 70 00
phone ext: +33
email: pierre.fournel@icloire.fr
last name: Véronique Régnier-Denois
phone: 04 77 91 74 75
phone ext: +33
email: veronique.regnier@icloire.fr
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No