<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/NCT02252991</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00091-46</org_study_id>
    <nct_id>NCT02252991</nct_id>
  </id_info>
  <brief_title>Adaptated Physical Activity in Cancerology</brief_title>
  <acronym>APACAN</acronym>
  <official_title>APACAN study_Adaptated Physical Activity in Cancerology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Jean Perrin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Jean Perrin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will measure the fatigue in breast cancer patients.&#xD;
&#xD;
      Two groups of patients will be realised:&#xD;
&#xD;
        -  Arm A: Physical activity during treatment&#xD;
&#xD;
        -  Arm B: No physical activity during treatment but after&#xD;
&#xD;
      The aim of the study is to decrease fatigue, with adequate physical activity, in primary&#xD;
      breast cancer patients who receive a treatment for their pathology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open monocentric study, randomized in two parallel arms with a waiting list.&#xD;
&#xD;
      The duration of the physical activty will vary according to the duration of the treatment:&#xD;
      from 2 to 6 months.&#xD;
&#xD;
      Several questionnaries (fatigue, quality of life, ...) will be given to patients at the&#xD;
      inclusion, at the end of the period of treatment and 3 to 6 months after the end of&#xD;
      treatment.&#xD;
&#xD;
      One hundred patients are necessary in this study (fifty in each arm). We expect to a&#xD;
      stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty to include patients&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The scores of fatigue at the end of treatment and at the inclusion will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QLQ-C30</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A with physical activity during the treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B with physical activity after the treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical activity</intervention_name>
    <description>Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.</description>
    <arm_group_label>Arm A with physical activity during the treatment</arm_group_label>
    <arm_group_label>Arm B with physical activity after the treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 to 75 years (included)&#xD;
&#xD;
          -  Patient with a breast tumor, regardless of the stage and size (except metastatic&#xD;
             patients)&#xD;
&#xD;
          -  Patient with a local recurrence of breast cancer&#xD;
&#xD;
          -  Patient with a second non-metastatic breast cancer&#xD;
&#xD;
          -  Breast cancer treated, regardless of the surgery, at least by radiotherapy,&#xD;
             chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy&#xD;
&#xD;
          -  A mandatory social security affiliation.&#xD;
&#xD;
          -  Obtaining informed consent in writing, signed and dated.&#xD;
&#xD;
          -  Medical certificate of fitness to practice physical (issued by the medical oncologist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer other than breast cancer and / or associated with breast cancer&#xD;
&#xD;
          -  Metastatic Cancer&#xD;
&#xD;
          -  in case of surgery before treatment, delay before beginning treatment inferior to 1&#xD;
             month post-surgery&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Woman pregnant&#xD;
&#xD;
          -  Patient with cognitive or psychiatric disorders&#xD;
&#xD;
          -  Patients suffering from disability&#xD;
&#xD;
          -  Significant alterations in nutritional status (malnutrition with BMI &lt;19, obese with&#xD;
             BMI&gt; 40, BMI)&#xD;
&#xD;
          -  Cardiac contraindication to physical activity&#xD;
&#xD;
          -  Knowledge and understanding of the French language enough not to learn the correct way&#xD;
             of self-administered questionnaires or respond to questioning&#xD;
&#xD;
          -  Participation in another clinical study with a similar objective&#xD;
&#xD;
          -  Inability to reach the centers where physical activity takes place&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yves Jean Bignon, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Jean Perrin</affiliation>
  </overall_official>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 23, 2015</last_update_submitted>
  <last_update_submitted_qc>December 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT02252991
org study id: 2014-A00091-46
nct id: NCT02252991
lead sponsor: 
has dmc: No
This trial will measure the fatigue in breast cancer patients.

      Two groups of patients will be realised:

        -  Arm A: Physical activity during treatment

        -  Arm B: No physical activity during treatment but after

      The aim of the study is to decrease fatigue, with adequate physical activity, in primary
      breast cancer patients who receive a treatment for their pathology.
This is an open monocentric study, randomized in two parallel arms with a waiting list.

      The duration of the physical activty will vary according to the duration of the treatment:
      from 2 to 6 months.

      Several questionnaries (fatigue, quality of life, ...) will be given to patients at the
      inclusion, at the end of the period of treatment and 3 to 6 months after the end of
      treatment.

      One hundred patients are necessary in this study (fifty in each arm). We expect to a
      stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.
time frame: up to 6 months
description: The scores of fatigue at the end of treatment and at the inclusion will be compared.
measure: QLQ-C30
time frame: up to 6 months
description: Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion.
arm group label: Arm A with physical activity during the treatment
arm group type: Other
description: In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.
arm group label: Arm B with physical activity after the treatment
arm group type: Other
description: In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.
intervention type: Other
intervention name: physical activity
description: Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.
arm group label: Arm A with physical activity during the treatment
arm group label: Arm B with physical activity after the treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yves Jean Bignon, MD,PhD
role: Principal Investigator
affiliation: Centre Jean Perrin
responsible party type: Sponsor
mesh term: Breast Neoplasms