<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/NCT03760653</url>
  </required_header>
  <id_info>
    <org_study_id>UEM0002</org_study_id>
    <nct_id>NCT03760653</nct_id>
  </id_info>
  <brief_title>Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.</brief_title>
  <acronym>ESICA</acronym>
  <official_title>Physical Activity Along With a Probiotic for the Immune System and Quality of Life Improvement in Breast Cancer Survivor: A Randomised Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Europea de Madrid</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>
      Physical exercise along with gut microbiota improvement -because of probiotic intake- can&#xD;
      improve the quality of life and immune system in breast cancer survivors. This is achieved&#xD;
      because exercise improves the muscle mass in cancer patients (often reduced by treatment&#xD;
      and/or inactivity), together with the gut microbiota improvement, this stimulates the inmune&#xD;
      system function, improving the quality of life of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to determine the effects of physical exercise together with the&#xD;
      supplementation of a probiotic on gut microbiota balance, the gut immune system and quality&#xD;
      of life (intended as functional and muscular capacity, physical qualities and emotional&#xD;
      state) in breast cancer survivors .&#xD;
&#xD;
      A randomized controlled pilot study has been designed in three parallel groups. Breast cancer&#xD;
      survivors will be randomly assigned to each of the 3 groups: a) probiotic supplementation +&#xD;
      supervised combined physical exercise (PEF), b) probiotic supplementation and habitual&#xD;
      sedentary lifestyle (P), and c) control group will follow their usual lifestyle and will&#xD;
      receive a placebo (C).&#xD;
&#xD;
      The exercise intervention will last 12 weeks. It will include three weekly sessions of&#xD;
      programmed physical exercise of ~ 60 min duration (combined training). The exercise program&#xD;
      will be individualized and will follow the rules of the world reference institutions for&#xD;
      aerobic training. Each session will be held in a qualified fitness center and it will be&#xD;
      supervised and individualized for each subject by professional experts .The two supplemented&#xD;
      groups will take 3 capsules (Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus&#xD;
      acidophilus, Bifidobacterium bifidum) a day (at night before bedtime) for 12 weeks.&#xD;
&#xD;
      The variables gut microbiota, fecal levels of immunoglobulin A, cardiorespiratory capacity,&#xD;
      anthropometry variables, lifestyle, muscular capacity, quality of life, anxiety, depression&#xD;
      and stress levels will be analized at the beginning (baseline dose) and after 12 weeks of&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The researcher who was able to recruit the patients abandoned the project.&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The probiotic and the placebo will be encapsulated in identical capsules and in identical cans that will only be identified with the letters A and B</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of life of breast cancer survivors</measure>
    <time_frame>Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Breast cancer survivors quality of life will be analyzed with the quality of life questionnaire from The European Organization for Research and Treatment of Cancer EORTC QLQ BR-23 test (a specific module for breast cancer survivors)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Functional capacity</measure>
    <time_frame>Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention</time_frame>
    <description>Dynamic fitness cardiorespiratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention</time_frame>
    <description>Body Mass Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscular Capacity</measure>
    <time_frame>Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.</time_frame>
    <description>Pressure manual test will be determined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary habits</measure>
    <time_frame>Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Food Frequency Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical activity level</measure>
    <time_frame>Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Physical activity questionnaire (IPAQ) will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety state</measure>
    <time_frame>Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression state</measure>
    <time_frame>Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Depression inventory (IDER)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Stress state</measure>
    <time_frame>Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Stress coping questionnarie for oncology patients will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gut Microbiota</measure>
    <time_frame>Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)</time_frame>
    <description>Microbial diversity, bifidobacteria and lactobacillus percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Immune system</measure>
    <time_frame>Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention</time_frame>
    <description>Fecal immunoglobulin A levels</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer Females</condition>
  <arm_group>
    <arm_group_label>Physical Exercise and probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will receive 3 weekly sessions of combined exercise supervised by professionals in a specialized gym (60 minutes each one). The exercise will consist of a combination of aerobic and strength exercises involving the main muscle groups. They will take the probiotic supplementation at the established dose, 3 capsules/day before bedtime. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will follow their usual sedentary lifestyle (i.e to practice less than 3 days a week of physical exercise, as is specified in the inclusion criteria). They will take the probiotic supplementation at the established dose. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>They will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Exercise and probiotic group</intervention_name>
    <description>The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of ~ 60 min duration (aerobic and strength combined training). The exercise sessions will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a authorized fitness center and it will be supervised and individualized for each subject by expert professionals.The probiotic will be taken (3 capsules/day) for 12 weeks. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.</description>
    <arm_group_label>Physical Exercise and probiotic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic group</intervention_name>
    <description>Probiotic supplementation (3 capsules/day) will be taken before bedtime for 12 weeks.Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.</description>
    <arm_group_label>Probiotic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo group</intervention_name>
    <description>Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast Cancer Survivors&#xD;
&#xD;
          -  &lt;18 aged.&#xD;
&#xD;
          -  No chemotherapy treatment or that at least three months have passed after the last&#xD;
             chemotherapy treatment before the beginning of the study.&#xD;
&#xD;
          -  Breast cancer status: I-IV status.&#xD;
&#xD;
          -  ECOG scale: 0-1.&#xD;
&#xD;
          -  Normal weight.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extreme Diet.&#xD;
&#xD;
          -  Exercise practice (at least at the doses recommended by WHO)&#xD;
&#xD;
          -  Presence of heart disease&#xD;
&#xD;
          -  Uncontrolled blood hypertension: (&gt;160/90 mmHg).&#xD;
&#xD;
          -  Uncontrolled metabolic disease&#xD;
&#xD;
          -  Infectious chronic disease&#xD;
&#xD;
          -  Uncontrolled pain&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Gastrointestinal disease&#xD;
&#xD;
          -  Alcoholism&#xD;
&#xD;
          -  Any condition that contraindicates the exercise practice in survivors cancer&#xD;
             (fractures risk, severe leukopenia , low platelet count)&#xD;
&#xD;
          -  Antibiotics intake during the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female breast cancer survivors</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Herrero, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centro medicina deportiva Miranda Ebro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mar Larrosa</name>
      <address>
        <city>Villaviciosa de Odón</city>
        <state>Madrid</state>
        <zip>28670</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>Mar Larrosa</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer Survivor</keyword>
  <keyword>Probiotic</keyword>
  <keyword>Immune System</keyword>
  <keyword>Physical Exercise</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Gut Microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03760653
org study id: UEM0002
nct id: NCT03760653
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical exercise along with gut microbiota improvement -because of probiotic intake- can
      improve the quality of life and immune system in breast cancer survivors. This is achieved
      because exercise improves the muscle mass in cancer patients (often reduced by treatment
      and/or inactivity), together with the gut microbiota improvement, this stimulates the inmune
      system function, improving the quality of life of these patients.
The aim of this study is to determine the effects of physical exercise together with the
      supplementation of a probiotic on gut microbiota balance, the gut immune system and quality
      of life (intended as functional and muscular capacity, physical qualities and emotional
      state) in breast cancer survivors .

      A randomized controlled pilot study has been designed in three parallel groups. Breast cancer
      survivors will be randomly assigned to each of the 3 groups: a) probiotic supplementation +
      supervised combined physical exercise (PEF), b) probiotic supplementation and habitual
      sedentary lifestyle (P), and c) control group will follow their usual lifestyle and will
      receive a placebo (C).

      The exercise intervention will last 12 weeks. It will include three weekly sessions of
      programmed physical exercise of ~ 60 min duration (combined training). The exercise program
      will be individualized and will follow the rules of the world reference institutions for
      aerobic training. Each session will be held in a qualified fitness center and it will be
      supervised and individualized for each subject by professional experts .The two supplemented
      groups will take 3 capsules (Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus
      acidophilus, Bifidobacterium bifidum) a day (at night before bedtime) for 12 weeks.

      The variables gut microbiota, fecal levels of immunoglobulin A, cardiorespiratory capacity,
      anthropometry variables, lifestyle, muscular capacity, quality of life, anxiety, depression
      and stress levels will be analized at the beginning (baseline dose) and after 12 weeks of
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The probiotic and the placebo will be encapsulated in identical capsules and in identical cans that will only be identified with the letters A and B
measure: Change in Quality of life of breast cancer survivors
time frame: Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Breast cancer survivors quality of life will be analyzed with the quality of life questionnaire from The European Organization for Research and Treatment of Cancer EORTC QLQ BR-23 test (a specific module for breast cancer survivors)
measure: Change in Functional capacity
time frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
description: Dynamic fitness cardiorespiratory
measure: Change in Body Composition
time frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
description: Body Mass Index
measure: Change in Muscular Capacity
time frame: Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
description: Pressure manual test will be determined
measure: Change in Dietary habits
time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Food Frequency Questionnaire
measure: Change in Physical activity level
time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Physical activity questionnaire (IPAQ) will be used
measure: Change in Anxiety state
time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: The State-Trait Anxiety Inventory (STAI)
measure: Change in Depression state
time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Depression inventory (IDER)
measure: Change Stress state
time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Stress coping questionnarie for oncology patients will be used
measure: Change in Gut Microbiota
time frame: Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
description: Microbial diversity, bifidobacteria and lactobacillus percentage
measure: Change in Immune system
time frame: Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
description: Fecal immunoglobulin A levels
arm group label: Physical Exercise and probiotic group
arm group type: Experimental
description: The subjects will receive 3 weekly sessions of combined exercise supervised by professionals in a specialized gym (60 minutes each one). The exercise will consist of a combination of aerobic and strength exercises involving the main muscle groups. They will take the probiotic supplementation at the established dose, 3 capsules/day before bedtime. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
arm group label: Probiotic group
arm group type: Experimental
description: Participants will follow their usual sedentary lifestyle (i.e to practice less than 3 days a week of physical exercise, as is specified in the inclusion criteria). They will take the probiotic supplementation at the established dose. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum
arm group label: Placebo group
arm group type: Placebo Comparator
description: They will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule.
intervention type: Other
intervention name: Physical Exercise and probiotic group
description: The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of ~ 60 min duration (aerobic and strength combined training). The exercise sessions will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a authorized fitness center and it will be supervised and individualized for each subject by expert professionals.The probiotic will be taken (3 capsules/day) for 12 weeks. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
arm group label: Physical Exercise and probiotic group
intervention type: Dietary Supplement
intervention name: Probiotic group
description: Probiotic supplementation (3 capsules/day) will be taken before bedtime for 12 weeks.Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
arm group label: Probiotic group
intervention type: Dietary Supplement
intervention name: Placebo group
description: Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks
arm group label: Placebo group
criteria: 
gender: Female
gender based: Yes
gender description: Female breast cancer survivors
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fernando Herrero, PhD
role: Study Director
affiliation: Centro medicina deportiva Miranda Ebro
facility: 
country: Spain
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responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: Mar Larrosa
investigator title: Senior Researcher
mesh term: Breast Neoplasms
sharing ipd: Undecided