<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/NCT01687335</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A00631-40</org_study_id>
    <secondary_id>2011-11</secondary_id>
    <nct_id>NCT01687335</nct_id>
  </id_info>
  <brief_title>Impact on the Nutritional State and the Quality of Life</brief_title>
  <official_title>Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is&#xD;
      variable in function: the location and the extension of the tumor, of the general state , of&#xD;
      age, of the socio-economic class and the pain. The health consequences of a malnutrition are&#xD;
      very important: aggravation of the state of health, complications of treatment,&#xD;
      hospitalization, alteration of the quality of life and decrease the survival, and the&#xD;
      treatment response.&#xD;
&#xD;
      Nutrition being very important in patients, there are recommendations for the nutritional&#xD;
      care of these patients, formulated by the European Society for Clinical Nutrition and&#xD;
      Metabolism. The investigators do not know to what extent these recommendations are respected&#xD;
      in practice and their influence on the nutritional status and the quality of life of&#xD;
      patients.&#xD;
&#xD;
      The investigators therefore propose to assess the conformity of the nutritional care patients&#xD;
      in clinical practice in relation to the European recommendations and in a second time to&#xD;
      assess the influence of this compliance or non-compliance on the nutritional status clinical&#xD;
      and biological of cancerous patients under chemotherapy, on their quality of life, on their&#xD;
      response to treatment and on their survival.&#xD;
&#xD;
      The investigators will try to identify factors that may be linked to the non-compliance such&#xD;
      as the characteristics of the cancer disease, socio-demographic characteristics of the&#xD;
      subject and the factors related to the structure in which it is supported.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2012</start_date>
  <completion_date type="Actual">March 31, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</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>quality of life's improvement</measure>
    <time_frame>3 YEARS</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>improvement of treatment effectiveness,</measure>
    <time_frame>3 YEARS</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>improvement of their survival</measure>
    <time_frame>3 YEARS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement of the screening of the undernutrition</measure>
    <time_frame>3 YEARS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the answer to the treatment</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the estimation of the survival with regard to the nutritional state of the patient.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>cancerous patients</arm_group_label>
    <description>the patients benefiting from treatment by chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>answering questionnare in differents time of the treatment</intervention_name>
    <arm_group_label>cancerous patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        cancerous patients benefiting from a treatment by chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-year-old subject in 85 years in the inclusion&#xD;
&#xD;
          -  Subject presenting a cancerous pathology requiring a systematic treatment by exclusive&#xD;
             chemotherapy for a minimal duration of three months with a plan of 3 cures of&#xD;
             chemotherapy with an interval between the cures of 21 days&#xD;
&#xD;
          -  Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive&#xD;
             ways superiors, sarcomas, colorectal cancers, broncho-lung cancers&#xD;
&#xD;
          -  Subject having the capacity of lira and to understand(include) French&#xD;
&#xD;
          -  Subject having signed lit(enlightened) consent&#xD;
&#xD;
          -  Subject taken care for its cancerous pathology in one of the partner services of the&#xD;
             project&#xD;
&#xD;
          -  Subject affiliated to the national insurance scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject having benefited from a major surgical operation in 4 weeks preceding the&#xD;
             inclusion&#xD;
&#xD;
          -  Subject having benefited from a radiotherapy in two weeks before the inclusion&#xD;
&#xD;
          -  Subject minor(miner), pregnant woman, subject incapable to give its consent, subject&#xD;
             under supervision(guardianship) - guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 6, 2011</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chemotherapy</keyword>
  <!-- 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/NCT01687335
org study id: 2011-A00631-40
secondary id: 2011-11
nct id: NCT01687335
lead sponsor: 
has dmc: No
The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is
      variable in function: the location and the extension of the tumor, of the general state , of
      age, of the socio-economic class and the pain. The health consequences of a malnutrition are
      very important: aggravation of the state of health, complications of treatment,
      hospitalization, alteration of the quality of life and decrease the survival, and the
      treatment response.

      Nutrition being very important in patients, there are recommendations for the nutritional
      care of these patients, formulated by the European Society for Clinical Nutrition and
      Metabolism. The investigators do not know to what extent these recommendations are respected
      in practice and their influence on the nutritional status and the quality of life of
      patients.

      The investigators therefore propose to assess the conformity of the nutritional care patients
      in clinical practice in relation to the European recommendations and in a second time to
      assess the influence of this compliance or non-compliance on the nutritional status clinical
      and biological of cancerous patients under chemotherapy, on their quality of life, on their
      response to treatment and on their survival.

      The investigators will try to identify factors that may be linked to the non-compliance such
      as the characteristics of the cancer disease, socio-demographic characteristics of the
      subject and the factors related to the structure in which it is supported.
observational model: Cohort
time perspective: Prospective
measure: quality of life's improvement
time frame: 3 YEARS
measure: improvement of treatment effectiveness,
time frame: 3 YEARS
measure: improvement of their survival
time frame: 3 YEARS
measure: improvement of the screening of the undernutrition
time frame: 3 YEARS
measure: the answer to the treatment
time frame: 3 years
measure: the estimation of the survival with regard to the nutritional state of the patient.
time frame: 3 years
arm group label: cancerous patients
description: the patients benefiting from treatment by chemotherapy.
intervention type: Other
intervention name: answering questionnare in differents time of the treatment
arm group label: cancerous patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor