<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/NCT03787966</url>
  </required_header>
  <id_info>
    <org_study_id>ATOPE18</org_study_id>
    <nct_id>NCT03787966</nct_id>
  </id_info>
  <brief_title>Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program</brief_title>
  <acronym>ATOPE</acronym>
  <official_title>Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine if therapeutic exercise before anticancer treatment&#xD;
      will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise&#xD;
      performed during anticancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The positive relationship between physical exercise and cancer is widely justified in the&#xD;
      literature, but an emerging research line warns of its capacity to improve the effectiveness&#xD;
      and reduce the toxicity of cancer treatment (responsible for the appearance of side effects&#xD;
      and comorbidities), that overload the health care system. To date, there is a lack of&#xD;
      knowledge in different subjects: the possibility of implementing individualized exercise&#xD;
      programs in clinical environment to mitigate the side effects of cancer treatment; the best&#xD;
      moment in natural history of the disease to perform therapeutic exercise; and a tailored dose&#xD;
      of exercise that maximizes its benefits.&#xD;
&#xD;
      In this context, the present study will evaluate the effects of a therapeutic exercise&#xD;
      program conducted previously at the beginning of the cancer treatment, in the treatments'&#xD;
      toxicity against the same program conducted during cancer treatments in women with breast&#xD;
      cancer, and its positive effects on both clinical and biological variables and their possible&#xD;
      impact on disease-free survival.&#xD;
&#xD;
      This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot&#xD;
      study be carried out to check the feasibility of the proposed physical exercise program;&#xD;
      phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical&#xD;
      treatment against the same made during treatment, with a randomized controlled clinical&#xD;
      trial; and phase 3: in which it will be integrated into the health service and a larger&#xD;
      project will be requested at the international level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>To assess cardiac toxicity by echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Number of cardiovascular events registered in a diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>To assess cardiac function by a Holter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate variability</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>To assess cardiac autonomic system balance by a Holter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle loss</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>To assess muscle mass loss by Inbody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life with the Quality of Life Questionnaire (QLQ)-C30</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.</measure>
    <time_frame>Participants will be followed over 12 months but will not be assessed in baseline</time_frame>
    <description>European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy regimen</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>type of chemotherapy agent used and number of sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy doses modifications</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>delay of doses or reduction, total doses received from the total expected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early session termination.</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Patient stopped receiving chemotherapy before last &gt;=1 sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missing bouts due to adverse effects of chemotherapy</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Adverse effects of chemotherapy treatment and if it was interrupted (&gt;=3 missing consecutive bouts of exercise)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations.</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic exercise bout modification</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>&gt;=1 bout that required a dose modification during the program and number of bouts modified in total.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program adverse effects reported by the participants.</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Frequency of serious and non-serious events occurring during program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by the 6-Minute Walking Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder strength</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb strength</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal strength</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by the Modified sit-and-reach test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist and hip circumferences</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by an inelastic tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>assessed by the InBody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Thiobarbituric acid reactive substances (TBARS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inmune function</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>C-reactive protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>interleukin (IL) 6 and 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>tumor necrosis factor (TNF) alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>Participants will be followed over 12 months</time_frame>
    <description>insulin-like growth factor 1 (IGF-1)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>ATOPE-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An adapted therapeutic exercise program performed before medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATOPE-I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An adapted therapeutic exercise program performed during medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ATOPE-B</intervention_name>
    <description>Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.</description>
    <arm_group_label>ATOPE-B</arm_group_label>
    <other_name>Therapeutic exercise before medical treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ATOPE-I</intervention_name>
    <description>Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.</description>
    <arm_group_label>ATOPE-I</arm_group_label>
    <other_name>Therapeutic exercise during medical treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Breast cancer diagnosis I-III stage&#xD;
&#xD;
          -  On the waiting list to anticancer medical treatment (at least surgery, chemotherapy&#xD;
             and radiotherapy.&#xD;
&#xD;
          -  If they meet other criteria which predisposes to higher toxicity.&#xD;
&#xD;
          -  Have signed informed consent.&#xD;
&#xD;
          -  Have medical clearance for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient underwent previous cancer treatments.&#xD;
&#xD;
          -  Patients were previously diagnosed with cancer.&#xD;
&#xD;
          -  Pregnant patients.&#xD;
&#xD;
          -  Patients performing other type of therapeutic exercise at diagnosis time with an&#xD;
             intake &gt;or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.&#xD;
&#xD;
          -  Therapeutic exercise practice not recommended because psychiatric or cognitive&#xD;
             disorders or cute or chronic condition that prevents exercise (advanced lung disease,&#xD;
             oxygen requirement, stenosis &gt;70%, metastasis etc.).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Cantarero-Villanueva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physical Therapy Deparment, Faculty of Health Sciences, University of Granada</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irene Cantarero-Villanueva, PhD</last_name>
    <phone>958248764</phone>
    <email>irenecantarero@ugr.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Granada</name>
      <address>
        <city>Granada</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene Cantarero-Villanueva, PhD</last_name>
      <phone>958248764</phone>
    </contact>
    <investigator>
      <last_name>Manuel Arroyo-Morales, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Irene Cantarero Villanueva</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast neoplasm</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>therapeutic exercise</keyword>
  <keyword>cardiotoxicity</keyword>
  <keyword>muscle toxicity</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/NCT03787966
org study id: ATOPE18
nct id: NCT03787966
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine if therapeutic exercise before anticancer treatment
      will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise
      performed during anticancer treatment.
The positive relationship between physical exercise and cancer is widely justified in the
      literature, but an emerging research line warns of its capacity to improve the effectiveness
      and reduce the toxicity of cancer treatment (responsible for the appearance of side effects
      and comorbidities), that overload the health care system. To date, there is a lack of
      knowledge in different subjects: the possibility of implementing individualized exercise
      programs in clinical environment to mitigate the side effects of cancer treatment; the best
      moment in natural history of the disease to perform therapeutic exercise; and a tailored dose
      of exercise that maximizes its benefits.

      In this context, the present study will evaluate the effects of a therapeutic exercise
      program conducted previously at the beginning of the cancer treatment, in the treatments'
      toxicity against the same program conducted during cancer treatments in women with breast
      cancer, and its positive effects on both clinical and biological variables and their possible
      impact on disease-free survival.

      This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot
      study be carried out to check the feasibility of the proposed physical exercise program;
      phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical
      treatment against the same made during treatment, with a randomized controlled clinical
      trial; and phase 3: in which it will be integrated into the health service and a larger
      project will be requested at the international level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Left ventricular ejection fraction
time frame: Participants will be followed over 12 months
description: To assess cardiac toxicity by echocardiography
measure: Cardiovascular events
time frame: Participants will be followed over 12 months
description: Number of cardiovascular events registered in a diary
measure: Resting heart rate
time frame: Participants will be followed over 12 months
description: To assess cardiac function by a Holter
measure: Heart Rate variability
time frame: Participants will be followed over 12 months
description: To assess cardiac autonomic system balance by a Holter
measure: Muscle loss
time frame: Participants will be followed over 12 months
description: To assess muscle mass loss by Inbody
measure: Quality of life with the Quality of Life Questionnaire (QLQ)-C30
time frame: Participants will be followed over 12 months
description: With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.
measure: Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.
time frame: Participants will be followed over 12 months but will not be assessed in baseline
description: European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.
measure: Chemotherapy regimen
time frame: Participants will be followed over 12 months
description: type of chemotherapy agent used and number of sessions.
measure: Chemotherapy doses modifications
time frame: Participants will be followed over 12 months
description: delay of doses or reduction, total doses received from the total expected.
measure: Early session termination.
time frame: Participants will be followed over 12 months
description: Patient stopped receiving chemotherapy before last >=1 sessions.
measure: Missing bouts due to adverse effects of chemotherapy
time frame: Participants will be followed over 12 months
description: Adverse effects of chemotherapy treatment and if it was interrupted (>=3 missing consecutive bouts of exercise)
measure: Number of hospitalizations.
time frame: Participants will be followed over 12 months
measure: Therapeutic exercise bout modification
time frame: Participants will be followed over 12 months
description: >=1 bout that required a dose modification during the program and number of bouts modified in total.
measure: Time to treatment failure
time frame: Participants will be followed over 12 months
description: days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.
measure: Program adverse effects reported by the participants.
time frame: Participants will be followed over 12 months
description: Frequency of serious and non-serious events occurring during program.
measure: Functional capacity
time frame: Participants will be followed over 12 months
description: assessed by the 6-Minute Walking Test
measure: Handgrip strength
time frame: Participants will be followed over 12 months
description: assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan
measure: Shoulder strength
time frame: Participants will be followed over 12 months
description: assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
measure: Lower limb strength
time frame: Participants will be followed over 12 months
description: assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
measure: Abdominal strength
time frame: Participants will be followed over 12 months
description: assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
measure: Flexibility
time frame: Participants will be followed over 12 months
description: assessed by the Modified sit-and-reach test
measure: Waist and hip circumferences
time frame: Participants will be followed over 12 months
description: assessed by an inelastic tape
measure: Body composition
time frame: Participants will be followed over 12 months
description: assessed by the InBody
measure: Oxidative stress
time frame: Participants will be followed over 12 months
description: Thiobarbituric acid reactive substances (TBARS)
measure: Oxidative stress
time frame: Participants will be followed over 12 months
description: carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)
measure: Inmune function
time frame: Participants will be followed over 12 months
description: Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)
measure: inflammation
time frame: Participants will be followed over 12 months
description: C-reactive protein (CRP)
measure: inflammation
time frame: Participants will be followed over 12 months
description: interleukin (IL) 6 and 10
measure: inflammation
time frame: Participants will be followed over 12 months
description: tumor necrosis factor (TNF) alpha
measure: inflammation
time frame: Participants will be followed over 12 months
description: insulin-like growth factor 1 (IGF-1)
arm group label: ATOPE-B
arm group type: Experimental
description: An adapted therapeutic exercise program performed before medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).
arm group label: ATOPE-I
arm group type: Active Comparator
description: An adapted therapeutic exercise program performed during medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).
intervention type: Other
intervention name: ATOPE-B
description: Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.
arm group label: ATOPE-B
other name: Therapeutic exercise before medical treatment
intervention type: Other
intervention name: ATOPE-I
description: Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.
arm group label: ATOPE-I
other name: Therapeutic exercise during medical treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Irene Cantarero-Villanueva, PhD
role: Principal Investigator
affiliation: Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
last name: Irene Cantarero-Villanueva, PhD
phone: 958248764
email: irenecantarero@ugr.es
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Irene Cantarero Villanueva
investigator title: Principal Investigator
mesh term: Breast Neoplasms