<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/NCT04451369</url>
  </required_header>
  <id_info>
    <org_study_id>TRAINING-01-IPC 2018-039</org_study_id>
    <nct_id>NCT04451369</nct_id>
  </id_info>
  <brief_title>Connected Prehabilitation Program During Neo Adjuvant Chemotherapy</brief_title>
  <acronym>TRAINING</acronym>
  <official_title>Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</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>
      NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and&#xD;
      emotional status. These three impairments are often ignored and not taken into account in the&#xD;
      pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality&#xD;
      after major surgery.&#xD;
&#xD;
      Recently, a prehabilitation before surgery, including physical, nutritional and psycho-social&#xD;
      support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max)&#xD;
      seems to constitute a strong evaluation factor reflecting physical fitness, easily measured&#xD;
      with a cardiopulmonary exercise test (CPET) at maximal effort.&#xD;
&#xD;
      Several studies have shown beneficial effects of trimodal prehabilitation programs on&#xD;
      postoperative functional capacity, return to daily activities and pain relief.&#xD;
&#xD;
      Home-based program and connected devices may improve the feasibility and the compliance to&#xD;
      this program.&#xD;
&#xD;
      The hypothesis of this study is that performing a connected supervised home-based and&#xD;
      patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or&#xD;
      without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit&#xD;
      physical fitness alteration and will positively affect postoperative outcomes.&#xD;
&#xD;
      Our study consists in an early and multidimensional (combining nutritional, physical,&#xD;
      emotional and medical support) prehabilitation program during NACT for patients with ovarian&#xD;
      cancer, in order to limit physical alteration before surgical treatment, and therefore&#xD;
      improve postoperative outcomes. It will include a home-based prehabilitation program, in&#xD;
      order to allow care access to all eligible patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective will be to determine if a prehabilitation program during NACT, for&#xD;
      patients treated for an advanced ovarian cancer will limit physical alteration before major&#xD;
      abdomino-pelvic surgery, compared to a control group without prehabilitation program. The&#xD;
      primary endpoint will be the comparison of the variation of VO2 max, between baseline and&#xD;
      surgery, in the prehabilitation group vs control group: VO2 max will be measured with a&#xD;
      cardiopulmonary exercise test (CPET) at maximal effort.&#xD;
&#xD;
      This prospective, multicentric randomized control trial will be conducted in 7 French&#xD;
      comprehensive cancer Centers or University Hospital, in compliance with inclusion criteria.&#xD;
      After an initial evaluation, patients will be randomized in two groups: Prehabilitation group&#xD;
      (P group) and a Control group (C group).&#xD;
&#xD;
      For the P group, after baseline evaluation, we will be offering from diagnosis to surgery,&#xD;
      during the NACT:&#xD;
&#xD;
        -  A standardized, patient-tailored preoperative physical activity training program will be&#xD;
           performed at home, from diagnosis to surgery. Supervision will be done with connected&#xD;
           device (connected watches) and activity will be adapted,&#xD;
&#xD;
        -  A nutritional care established in respect of the SFNEP-SFNCM guidelines. Nutritional&#xD;
           support will be adapted by a dietician according to information transmitted daily&#xD;
           (connected body fat weight scale),&#xD;
&#xD;
        -  A psychological support with coping strategies.&#xD;
&#xD;
      For the C group: Patients with ovarian cancer will undergo NACT after baseline evaluation&#xD;
      without prehabilitation program.&#xD;
&#xD;
      After NACT, for both groups, major abdomino-pelvic surgery will be done with or without ERAS&#xD;
      pathway, according to the practice in each center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 2021</start_date>
  <completion_date type="Anticipated">September 2027</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine if a prehabilitation program during NACT, for patient managed with advanced ovarian cancer (AOC) will limit physical alteration before surgery, compared to a control group without prehabilitation program (change between 3 timepoints).</measure>
    <time_frame>baseline, 15 days before surgery and 3 moths before surgery</time_frame>
    <description>CHANGE of VO2 max between baseline (inclusion) and surgery (preoperative), in the prehabilitation group vs control group. VO2 max will be measured during a cardiopulmonary exercise test (CPET).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>to compare physical outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>o International Physical Activity Questionnaire (IPAQ) , administered at inclusion and at the time of surgery and after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare physical outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Muscular strength evaluated with dynamometer (brachial biceps)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare Quality of Life, emotional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare Quality of Life, emotional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Cancer related quality of life (QoL) evaluated by using the self-reported European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) (Annex 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare Quality of Life, emotional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Motivation evaluated by a free interview and a coping strategy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare nutritional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Change Body Mass Index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare nutritional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Muscle mass evaluated with the Computed tomography-derived</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare nutritional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare nutritional outcomes between both groups</measure>
    <time_frame>baseline, before surgery, and 3 months after surgery</time_frame>
    <description>Weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare Surgical Morbidity rate between both groups</measure>
    <time_frame>at day 30 and day 90 (3 months) after surgery</time_frame>
    <description>Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to compare Surgical Morbidity rate between both groups</measure>
    <time_frame>at day 30 and day 90 (3 months) after surgery</time_frame>
    <description>NCI-CTCAE v 5.0 classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group without prehabilitation program before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prehabilitation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group will follows a prehabilitation program before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation program</intervention_name>
    <description>physical, nutritional and psycho-social supports before surgery</description>
    <arm_group_label>Prehabilitation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must have signed the written consent,&#xD;
&#xD;
          2. Age ≥ 18 years,&#xD;
&#xD;
          3. Patient with advanced ovarian cancer (AOC), FIGO Stage III - IV, undergoing surgery,&#xD;
&#xD;
          4. Patient with neo adjuvant chemotherapy (min 3 cycles, max 6 cycles),&#xD;
&#xD;
          5. Capability to perform a cardiopulmonary exercise test (CPET)&#xD;
&#xD;
          6. Patient affiliated to the national &quot;Social Security&quot; regimen or beneficiary of this&#xD;
             regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with cognitive impairment,&#xD;
&#xD;
          2. Pregnancy,&#xD;
&#xD;
          3. Neoadjuvant treatment contraindications,&#xD;
&#xD;
          4. Physical adapted activity program contraindication,&#xD;
&#xD;
          5. No possibility to have access to connected devices or do not have a smartphone or a&#xD;
             computer&#xD;
&#xD;
          6. Patient deprived of liberty or placed under the authority of a tutor,&#xD;
&#xD;
          7. Patient considered socially or psychologically unable to comply with the procedure and&#xD;
             the required medical follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Ovarian cancer.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dominique GENRE, Dr</last_name>
    <phone>+33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <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/NCT04451369
org study id: TRAINING-01-IPC 2018-039
nct id: NCT04451369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and
      emotional status. These three impairments are often ignored and not taken into account in the
      pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality
      after major surgery.

      Recently, a prehabilitation before surgery, including physical, nutritional and psycho-social
      support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max)
      seems to constitute a strong evaluation factor reflecting physical fitness, easily measured
      with a cardiopulmonary exercise test (CPET) at maximal effort.

      Several studies have shown beneficial effects of trimodal prehabilitation programs on
      postoperative functional capacity, return to daily activities and pain relief.

      Home-based program and connected devices may improve the feasibility and the compliance to
      this program.

      The hypothesis of this study is that performing a connected supervised home-based and
      patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or
      without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit
      physical fitness alteration and will positively affect postoperative outcomes.

      Our study consists in an early and multidimensional (combining nutritional, physical,
      emotional and medical support) prehabilitation program during NACT for patients with ovarian
      cancer, in order to limit physical alteration before surgical treatment, and therefore
      improve postoperative outcomes. It will include a home-based prehabilitation program, in
      order to allow care access to all eligible patients.
The main objective will be to determine if a prehabilitation program during NACT, for
      patients treated for an advanced ovarian cancer will limit physical alteration before major
      abdomino-pelvic surgery, compared to a control group without prehabilitation program. The
      primary endpoint will be the comparison of the variation of VO2 max, between baseline and
      surgery, in the prehabilitation group vs control group: VO2 max will be measured with a
      cardiopulmonary exercise test (CPET) at maximal effort.

      This prospective, multicentric randomized control trial will be conducted in 7 French
      comprehensive cancer Centers or University Hospital, in compliance with inclusion criteria.
      After an initial evaluation, patients will be randomized in two groups: Prehabilitation group
      (P group) and a Control group (C group).

      For the P group, after baseline evaluation, we will be offering from diagnosis to surgery,
      during the NACT:

        -  A standardized, patient-tailored preoperative physical activity training program will be
           performed at home, from diagnosis to surgery. Supervision will be done with connected
           device (connected watches) and activity will be adapted,

        -  A nutritional care established in respect of the SFNEP-SFNCM guidelines. Nutritional
           support will be adapted by a dietician according to information transmitted daily
           (connected body fat weight scale),

        -  A psychological support with coping strategies.

      For the C group: Patients with ovarian cancer will undergo NACT after baseline evaluation
      without prehabilitation program.

      After NACT, for both groups, major abdomino-pelvic surgery will be done with or without ERAS
      pathway, according to the practice in each center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To determine if a prehabilitation program during NACT, for patient managed with advanced ovarian cancer (AOC) will limit physical alteration before surgery, compared to a control group without prehabilitation program (change between 3 timepoints).
time frame: baseline, 15 days before surgery and 3 moths before surgery
description: CHANGE of VO2 max between baseline (inclusion) and surgery (preoperative), in the prehabilitation group vs control group. VO2 max will be measured during a cardiopulmonary exercise test (CPET).
measure: to compare physical outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: o International Physical Activity Questionnaire (IPAQ) , administered at inclusion and at the time of surgery and after surgery
measure: to compare physical outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Muscular strength evaluated with dynamometer (brachial biceps)
measure: to compare Quality of Life, emotional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)
measure: to compare Quality of Life, emotional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Cancer related quality of life (QoL) evaluated by using the self-reported European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) (Annex 3)
measure: to compare Quality of Life, emotional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Motivation evaluated by a free interview and a coping strategy.
measure: to compare nutritional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Change Body Mass Index (BMI)
measure: to compare nutritional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Muscle mass evaluated with the Computed tomography-derived
measure: to compare nutritional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2
measure: to compare nutritional outcomes between both groups
time frame: baseline, before surgery, and 3 months after surgery
description: Weight in kg
measure: to compare Surgical Morbidity rate between both groups
time frame: at day 30 and day 90 (3 months) after surgery
description: Clavien-Dindo classification
measure: to compare Surgical Morbidity rate between both groups
time frame: at day 30 and day 90 (3 months) after surgery
description: NCI-CTCAE v 5.0 classification
arm group label: Control group
arm group type: No Intervention
description: Group without prehabilitation program before surgery
arm group label: Prehabilitation group
arm group type: Experimental
description: Group will follows a prehabilitation program before surgery
intervention type: Other
intervention name: Prehabilitation program
description: physical, nutritional and psycho-social supports before surgery
arm group label: Prehabilitation group
criteria: 
gender: Female
gender based: Yes
gender description: Ovarian cancer.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique GENRE, Dr
phone: +33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No