<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/NCT03773003</url>
  </required_header>
  <id_info>
    <org_study_id>IMPROFA</org_study_id>
    <nct_id>NCT03773003</nct_id>
  </id_info>
  <brief_title>Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)</brief_title>
  <acronym>IMPROFA</acronym>
  <official_title>Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) by Lipidomics, Metabolomics, Microbiome and Exome Analysis and Investigation of Clinical Improvement Under Administration of Probiotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Saarland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universität des Saarlandes</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>
      Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome&#xD;
      (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome&#xD;
      Analysis and Investigation of a Possible Benefit of Probiotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by&#xD;
      screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease&#xD;
      with and without fatigue. These results will be compared to an age- and gender matched&#xD;
      control group with a comparable tumor disease and to another age- and gender matched control&#xD;
      group without tumor disease.&#xD;
&#xD;
      The investigators are following the same strategy for investigating an underlying&#xD;
      pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age-&#xD;
      and gender matched control group will be established from the beforementioned control group.&#xD;
&#xD;
      The investigators will also be screening for a peritoneal microbiome (possible correlate for&#xD;
      leaky gut) in study patients undergoing abdominal surgery.&#xD;
&#xD;
      We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome&#xD;
      by double-blinded, placebo-controlled administration of probiotics to the study population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2024</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>
    <intervention_model_description>Double blinded, placebo controlled intervention with probiotics&#xD;
There are three groups in the study:&#xD;
Tumor disease with fatigue&#xD;
Tumor disease without fatigue&#xD;
Healthy control group</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of fatigue symptoms</measure>
    <time_frame>3 months after end of chemotherapy</time_frame>
    <description>Improvement of fatigue as measured by validated psychometric questionnaires.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cancer Related Fatigue</condition>
  <condition>Fatigue Syndrome, Chronic</condition>
  <arm_group>
    <arm_group_label>Arm 1: Tumor disease w/o fatigue</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group receiving probiotics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Tumor disease w/o fatigue</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group receiving placebo (corn starch)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3: Healthy control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group receiving probiotics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4: Healthy control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group receiving placebo (corn starch)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>The administered probiotics are readily available on the market and contain&#xD;
Bifidobacterium breve, B. infantis, B. lactis, B. longum&#xD;
Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius&#xD;
Streptococcus thermophilus</description>
    <arm_group_label>Arm 1: Tumor disease w/o fatigue</arm_group_label>
    <arm_group_label>Arm 3: Healthy control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Identically looking to verum, containing corn starch.</description>
    <arm_group_label>Arm 2: Tumor disease w/o fatigue</arm_group_label>
    <arm_group_label>Arm 4: Healthy control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically, cytologically or radiologically confirmed tumor disease&#xD;
&#xD;
          -  indication for chemotherapy&#xD;
&#xD;
          -  Written consent to participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic-inflammatory bowel disease&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Jelden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Saarland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Jelden, MD</last_name>
    <phone>+4968411630000</phone>
    <email>michael.jelden@uks.eu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Saarland University Medical Center</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66424</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Jelden, Dr.</last_name>
      <phone>+49684116</phone>
      <phone_ext>30000</phone_ext>
      <email>michael.jelden@uks.eu</email>
    </contact>
    <contact_backup>
      <last_name>Michael Jelden, Dr.</last_name>
      <phone>49684116</phone>
      <phone_ext>15000</phone_ext>
      <email>michael.jelden@uks.eu</email>
    </contact_backup>
    <investigator>
      <last_name>Michael Jelden, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Saarland</investigator_affiliation>
    <investigator_full_name>Michael Jelden</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cancer Fatigue, Chronic Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Fatigue</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/NCT03773003
org study id: IMPROFA
nct id: NCT03773003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome
      (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome
      Analysis and Investigation of a Possible Benefit of Probiotics.
This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by
      screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease
      with and without fatigue. These results will be compared to an age- and gender matched
      control group with a comparable tumor disease and to another age- and gender matched control
      group without tumor disease.

      The investigators are following the same strategy for investigating an underlying
      pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age-
      and gender matched control group will be established from the beforementioned control group.

      The investigators will also be screening for a peritoneal microbiome (possible correlate for
      leaky gut) in study patients undergoing abdominal surgery.

      We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome
      by double-blinded, placebo-controlled administration of probiotics to the study population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blinded, placebo controlled intervention with probiotics
There are three groups in the study:
Tumor disease with fatigue
Tumor disease without fatigue
Healthy control group
primary purpose: Basic Science
masking: Single (Investigator)
masking description: Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.
measure: Improvement of fatigue symptoms
time frame: 3 months after end of chemotherapy
description: Improvement of fatigue as measured by validated psychometric questionnaires.
arm group label: Arm 1: Tumor disease w/o fatigue
arm group type: Active Comparator
description: Group receiving probiotics.
arm group label: Arm 2: Tumor disease w/o fatigue
arm group type: Placebo Comparator
description: Group receiving placebo (corn starch)
arm group label: Arm 3: Healthy control group
arm group type: Active Comparator
description: Group receiving probiotics
arm group label: Arm 4: Healthy control group
arm group type: Placebo Comparator
description: Group receiving placebo (corn starch)
intervention type: Dietary Supplement
intervention name: Probiotics
description: The administered probiotics are readily available on the market and contain
Bifidobacterium breve, B. infantis, B. lactis, B. longum
Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius
Streptococcus thermophilus
arm group label: Arm 1: Tumor disease w/o fatigue
arm group label: Arm 3: Healthy control group
intervention type: Dietary Supplement
intervention name: Placebo
description: Identically looking to verum, containing corn starch.
arm group label: Arm 2: Tumor disease w/o fatigue
arm group label: Arm 4: Healthy control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Jelden, MD
role: Principal Investigator
affiliation: University Hospital, Saarland
last name: Michael Jelden, MD
phone: +4968411630000
email: michael.jelden@uks.eu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Saarland
investigator full name: Michael Jelden
investigator title: Principal Investigator
mesh term: Fatigue Syndrome, Chronic
mesh term: Fatigue