<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/NCT04478175</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2020-01</org_study_id>
    <nct_id>NCT04478175</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology</brief_title>
  <acronym>DParcoursDig</acronym>
  <official_title>Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</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 with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished&#xD;
      at diagnosis (&gt; 60% of cases) and at high risk of rapid clinical deterioration. These&#xD;
      patients have important supportive care needs that represent a major challenge for improving&#xD;
      treatment tolerance and patient survival and health-related quality of life (HRQoL).&#xD;
&#xD;
      Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased&#xD;
      risk of death, complications from chemotherapy, infections, emergency procedures and&#xD;
      hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia&#xD;
      represent a major clinical target in GI cancers.&#xD;
&#xD;
      Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in&#xD;
      patients' pathways, these syndromes being reversible at early stages but not at late stages.&#xD;
&#xD;
      A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional&#xD;
      support and and adapted physical activity (APA) in addition to anticancer treatments should&#xD;
      be systematically implemented in patients with advanced GI cancers.&#xD;
&#xD;
      This type of intervention complies with the standards recommended by the National Cancer&#xD;
      Institute (INCa) to promote the practice of physical activity during and after treatment in&#xD;
      oncology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will receive usual care including:&#xD;
&#xD;
        -  Chemotherapy at the investigator's choice,&#xD;
&#xD;
        -  Outpatient clinical visits according to the regular schedule,&#xD;
&#xD;
        -  Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with&#xD;
           intravenous contrast injection every 8 weeks.&#xD;
&#xD;
      Nutritional support will consist of:&#xD;
&#xD;
        -  A nutrition assessment by a dietician including a VAS of food intakes at baseline, at W4&#xD;
           and W8 (plus additional visits if required),&#xD;
&#xD;
        -  Nutritional intervention according to the Société Francophone de Nutrition Clinique et&#xD;
           Métabolisme (SFNEP) guidelines (dietetic counseling for all patients ± oral&#xD;
           supplementation, enteral tube feeding, and/or parenteral nutrition).&#xD;
&#xD;
      Physical activity support will consist of physical condition assessed by International&#xD;
      Physical Activity Questionnaire (IPAQ), performance status (ECOG PS), resting heart rate and&#xD;
      blood pressure, 6-minute walking test (speed, fatigue), handgrip test, chair stand fitness&#xD;
      test, get-up and go test, balance in single-leg and bipodal stance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2021</start_date>
  <completion_date type="Actual">October 5, 2022</completion_date>
  <primary_completion_date type="Actual">October 5, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Program faisability</measure>
    <time_frame>12 months</time_frame>
    <description>Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dimensions of EORTC QLQ-C30</measure>
    <time_frame>12 months</time_frame>
    <description>EORTC QLQ-C30 completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue measured by Visual Analogue Scale (VAS)</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measured by VAS and analgesics consumption</measure>
    <time_frame>12 months</time_frame>
    <description>VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status/inflammation measure</measure>
    <time_frame>12 months</time_frame>
    <description>weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition assessed</measure>
    <time_frame>12 months</time_frame>
    <description>International Physical Activity Questionnaire (IPAQ),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric assessment if age ≥ 70</measure>
    <time_frame>12 months</time_frame>
    <description>G8 score from 0 to 17</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy tolerance assessed</measure>
    <time_frame>12 months</time_frame>
    <description>toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival and Overall Survival</measure>
    <time_frame>12 months</time_frame>
    <description>Progression Free Survival and Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction measured by VAS</measure>
    <time_frame>12 months</time_frame>
    <description>VAS completion with a score from 0 to 10</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma)</condition>
  <condition>Colorectal With Associated Risk Factors</condition>
  <arm_group>
    <arm_group_label>Patients with advanced gastrointestinal (GI) cancers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will receive usual care including:&#xD;
Chemotherapy at the investigator's choice,&#xD;
Outpatient clinical visits according to the regular schedule,&#xD;
Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks.&#xD;
Nutritional support will consist of:&#xD;
A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required),&#xD;
Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition).&#xD;
Physical activity support will consist of:&#xD;
A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8,&#xD;
Personalized counselling for unsupervised home-based exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>multidisciplinary assessment and intervention</intervention_name>
    <description>early multidisciplinary assessment and intervention in addition to usual patient care</description>
    <arm_group_label>Patients with advanced gastrointestinal (GI) cancers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent,&#xD;
&#xD;
          2. Age ≥ 18 years (no superior limit),&#xD;
&#xD;
          3. Histologically confirmed (1) non-colorectal cancer (esophagus, stomach, liver/bile&#xD;
             ducts, pancreas, neuroendocrine carcinoma) or (2) colorectal with associated risk&#xD;
             factors i.e. ECOG PS 2 (defining significant limitation in daily activities), and/or&#xD;
             weight loss ≥ 5% in 1 month or ≥ 10% in 6 months (defining malnutrition/HAS 2019),&#xD;
&#xD;
          4. Advanced disease not amenable to surgery, radiation, or combined modality therapy with&#xD;
             curative intent (previous resection of primary tumor allowed), treated with first-line&#xD;
             chemotherapy for advanced disease (previous [neo]adjuvant chemo[radio]therapy&#xD;
             allowed); or resectable/potentially resectable disease receiving a triplet&#xD;
             chemotherapy regimen in a peri-operative setting (e.g. FOLFIRINOX, FLOT) (moderate&#xD;
             risk at frailty score)&#xD;
&#xD;
          5. Patients able to attend for administration of chemotherapy,&#xD;
&#xD;
          6. Life expectancy ≥ 3 months,&#xD;
&#xD;
          7. Registration in a National Health Care System (Couverture Maladie Universelle [CMU]&#xD;
             included).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other active non gastro-intestinal cancers&#xD;
&#xD;
          2. Any medical (including psychiatric, musculoskeletal, or neurological) condition&#xD;
             contra-indicating exercise practice,&#xD;
&#xD;
          3. Pregnancy or breastfeeding,&#xD;
&#xD;
          4. Protected adults (individuals under guardianship by court order).&#xD;
&#xD;
        Note: participation to another concomitant clinical trial is allowed, but the patient must&#xD;
        inform the Investigator and get an authorization from the Sponsor.&#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>Véronique GILLON</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Curie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advanced gastrointestinal (GI) cancers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Neuroendocrine</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/NCT04478175
org study id: IC 2020-01
nct id: NCT04478175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished
      at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These
      patients have important supportive care needs that represent a major challenge for improving
      treatment tolerance and patient survival and health-related quality of life (HRQoL).

      Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased
      risk of death, complications from chemotherapy, infections, emergency procedures and
      hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia
      represent a major clinical target in GI cancers.

      Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in
      patients' pathways, these syndromes being reversible at early stages but not at late stages.

      A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional
      support and and adapted physical activity (APA) in addition to anticancer treatments should
      be systematically implemented in patients with advanced GI cancers.

      This type of intervention complies with the standards recommended by the National Cancer
      Institute (INCa) to promote the practice of physical activity during and after treatment in
      oncology.
All patients will receive usual care including:

        -  Chemotherapy at the investigator's choice,

        -  Outpatient clinical visits according to the regular schedule,

        -  Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with
           intravenous contrast injection every 8 weeks.

      Nutritional support will consist of:

        -  A nutrition assessment by a dietician including a VAS of food intakes at baseline, at W4
           and W8 (plus additional visits if required),

        -  Nutritional intervention according to the Société Francophone de Nutrition Clinique et
           Métabolisme (SFNEP) guidelines (dietetic counseling for all patients ± oral
           supplementation, enteral tube feeding, and/or parenteral nutrition).

      Physical activity support will consist of physical condition assessed by International
      Physical Activity Questionnaire (IPAQ), performance status (ECOG PS), resting heart rate and
      blood pressure, 6-minute walking test (speed, fatigue), handgrip test, chair stand fitness
      test, get-up and go test, balance in single-leg and bipodal stance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Program faisability
time frame: 12 months
description: Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments
measure: Dimensions of EORTC QLQ-C30
time frame: 12 months
description: EORTC QLQ-C30 completion
measure: Fatigue measured by Visual Analogue Scale (VAS)
time frame: 12 months
description: Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
measure: Pain measured by VAS and analgesics consumption
time frame: 12 months
description: VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose
measure: Nutritional status/inflammation measure
time frame: 12 months
description: weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes
measure: Physical condition assessed
time frame: 12 months
description: International Physical Activity Questionnaire (IPAQ),
measure: Geriatric assessment if age ≥ 70
time frame: 12 months
description: G8 score from 0 to 17
measure: Chemotherapy tolerance assessed
time frame: 12 months
description: toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])
measure: Progression Free Survival and Overall Survival
time frame: 12 months
description: Progression Free Survival and Overall Survival
measure: Patient's satisfaction measured by VAS
time frame: 12 months
description: VAS completion with a score from 0 to 10
arm group label: Patients with advanced gastrointestinal (GI) cancers
arm group type: Other
description: All patients will receive usual care including:
Chemotherapy at the investigator's choice,
Outpatient clinical visits according to the regular schedule,
Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks.
Nutritional support will consist of:
A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required),
Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition).
Physical activity support will consist of:
A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8,
Personalized counselling for unsupervised home-based exercises
intervention type: Other
intervention name: multidisciplinary assessment and intervention
description: early multidisciplinary assessment and intervention in addition to usual patient care
arm group label: Patients with advanced gastrointestinal (GI) cancers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Véronique GILLON
role: Study Chair
affiliation: Institut Curie
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Neuroendocrine