<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/NCT02240836</url>
  </required_header>
  <id_info>
    <org_study_id>2014/945-1</org_study_id>
    <nct_id>NCT02240836</nct_id>
  </id_info>
  <brief_title>Energy Balance and Breast Cancer Aspects-II</brief_title>
  <acronym>EBBA-II</acronym>
  <official_title>Energy Balance and Breast Cancer Aspects-II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise&#xD;
      program comprised of strength and endurance training among newly diagnosed breast cancer&#xD;
      patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims&#xD;
      are to determine whether the 12 month exercise program will influence factors associated with&#xD;
      metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer&#xD;
      specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be&#xD;
      assessed and evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EBBA (Energy Balance and Breast cancer Aspects)-II study is a randomized clinical 12&#xD;
      month physical activity intervention trial, including female breast cancer patients diagnosed&#xD;
      with histologically verified invasive cancer stage I-II or carcinoma in situ (DCIS/LCIS)&#xD;
      grade 3.&#xD;
&#xD;
        -  Participants are randomized to either control or intervention group 10 days +/- 2 days&#xD;
           after surgery. The intervention start 3 weeks after surgery and continue throughout&#xD;
           adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). The&#xD;
           intervention group receive a detailed training program based on their own ventilatory&#xD;
           maximal oxygen consumption (VO2max) at baseline. They meet for supervised training&#xD;
           sessions in groups for 60 minutes x 2/ week during 12 months. In addition, they are&#xD;
           informed to exercise at home for at least of total 120 minutes weekly aiming to perform&#xD;
           a total of 240 minutes exercise, weekly. The patients in the control group receive&#xD;
           standard of care without any restrictions regarding exercise.&#xD;
&#xD;
        -  All participants will undergo a series of measurements before surgery, after surgery, 6&#xD;
           months and after the 12 months exercise intervention trial. Clinical measurements will&#xD;
           include anthropometric measurements, fasting blood, fecal and urine samples and&#xD;
           cardiopulmonary exercise test (CPET). Complete questionnaires (food diary (PFD)/food&#xD;
           frequency questionnaires (FFQ), quality of life (QoL)).&#xD;
&#xD;
        -  All participants will come to clinical examination and fasting blood sampling after 2,&#xD;
           3, 5 and 10 years follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">October 31, 2027</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VO2max</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in VO2max from baseline to 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in BMI from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in systolic blood pressure from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in diastolic blood pressure from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in total cholesterol from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in LDL cholesterol from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in HDL cholesterol from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol/HDL cholesterol</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in total cholesterol/HDL cholesterol from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in concentrations of HbA1c from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in concentrations of triglycerides from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein (CRP)</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in concentrations of CRP (mg/L) from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in heart rate from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fat</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in total fat from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Truncated fat</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in truncated fat from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in waist circumference from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy from food diary</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Change in energy from food diary from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic syndrome</measure>
    <time_frame>12 months</time_frame>
    <description>Dichotomous outcome (yes/no)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Respiratory Quotient (RQ)</measure>
    <time_frame>12 months</time_frame>
    <description>Ratio between the amount of CO2 produced in metabolism and O2 used</description>
  </other_outcome>
  <other_outcome>
    <measure>Lactate</measure>
    <time_frame>12 months</time_frame>
    <description>Blood lactate from fingertip one minute after test</description>
  </other_outcome>
  <other_outcome>
    <measure>HRmax</measure>
    <time_frame>12 months</time_frame>
    <description>Maximal heart rate</description>
  </other_outcome>
  <other_outcome>
    <measure>BORGmax</measure>
    <time_frame>12 months</time_frame>
    <description>Subjective measure of exhaustion</description>
  </other_outcome>
  <other_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>Baseline, 1 year, 2 years, 5 years, 10 years</time_frame>
    <description>Time from baseline to the date of cancer symptoms or death</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall mortality</measure>
    <time_frame>Baseline, 1 year, 2 years, 5 years, 10 years</time_frame>
    <description>Time from baseline until the date of death, regardless of the cause of death</description>
  </other_outcome>
  <other_outcome>
    <measure>Breast cancer-specific mortality</measure>
    <time_frame>Baseline, 1 year, 2 years, 5 years, 10 years</time_frame>
    <description>Time from baseline until the date of breast cancer-specific death</description>
  </other_outcome>
  <other_outcome>
    <measure>Other exploratory</measure>
    <time_frame>12 months</time_frame>
    <description>Forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), diffusing capacity of the lung for carbon monoxide (DLco)&#xD;
Inflammatory markers, prothrombotic markers, urinary markers, adipokines&#xD;
Levels of sex steroid hormones&#xD;
Growth factors (Insulin-like growth factor [IGF], insulin, insulin-like growth factor binding protein [IGFBP])&#xD;
Microenvironment of the breast, tumor infiltrating lymphocytes (TILS), Crown like structures (CLS)&#xD;
Microbiota&#xD;
Quality of life and dietary factors</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">545</enrollment>
  <condition>DCIS Grade 3</condition>
  <condition>Stage I Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>LCIS, Lobular Carcinoma in Situ</condition>
  <arm_group>
    <arm_group_label>Intervention. Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention starts 3-4 weeks after surgical treatment. The exercise program is performed in parallel with standard breast cancer treatment, and take place in supervised exercise groups by experienced physiotherapists. The duration of the intervention exercise program is 12 months, and the participants will attend the exercise groups for training 60 minutes twice a week. Additionally, they will exercise at home for at least 120 minutes a week, aiming to perform a total of 240 minutes of exercise per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group, standard treatment regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention. Exercise</intervention_name>
    <description>Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.</description>
    <arm_group_label>Intervention. Exercise</arm_group_label>
    <other_name>Physical activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
          -  Newly diagnosed DCIS grade 3 or invasive breast cancer stage I, II, histologically&#xD;
             verified.&#xD;
&#xD;
          -  All ethnic groups, but participants have to speak and write the Norwegian language.&#xD;
&#xD;
          -  Ability to join and maintain an intervention for 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Verified heart disease&#xD;
&#xD;
          -  Dysregulated diabetes mellitus or thyroid disorders&#xD;
&#xD;
          -  Muscular and skeletal or other disorders excluding regular physical activity&#xD;
             performance&#xD;
&#xD;
          -  Body Mass Index &gt;40 kg/m2&#xD;
&#xD;
          -  Previous surgical treatment for obesity&#xD;
&#xD;
          -  Travel distance &gt;1.5 hour from home to study site&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inger Thune, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Department of Oncology, Ullevål, Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7000</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Thune I, Njolstad I, Lochen ML, Forde OH. Physical activity improves the metabolic risk profiles in men and women: the Tromso Study. Arch Intern Med. 1998 Aug 10-24;158(15):1633-40. doi: 10.1001/archinte.158.15.1633. Erratum In: Arch Intern Med 1998 Jan 11;159(1):17.</citation>
    <PMID>9701097</PMID>
  </reference>
  <reference>
    <citation>Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. doi: 10.1001/jama.289.3.323.</citation>
    <PMID>12525233</PMID>
  </reference>
  <reference>
    <citation>Furberg AS, Veierod MB, Wilsgaard T, Bernstein L, Thune I. Serum high-density lipoprotein cholesterol, metabolic profile, and breast cancer risk. J Natl Cancer Inst. 2004 Aug 4;96(15):1152-60. doi: 10.1093/jnci/djh216.</citation>
    <PMID>15292387</PMID>
  </reference>
  <reference>
    <citation>Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.</citation>
    <PMID>14744958</PMID>
  </reference>
  <reference>
    <citation>Courneya KS, Segal RJ, McKenzie DC, Dong H, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Crawford JJ, Mackey JR. Effects of exercise during adjuvant chemotherapy on breast cancer outcomes. Med Sci Sports Exerc. 2014 Sep;46(9):1744-51. doi: 10.1249/MSS.0000000000000297.</citation>
    <PMID>24633595</PMID>
  </reference>
  <reference>
    <citation>Friedenreich CM, Woolcott CG, McTiernan A, Ballard-Barbash R, Brant RF, Stanczyk FZ, Terry T, Boyd NF, Yaffe MJ, Irwin ML, Jones CA, Yasui Y, Campbell KL, McNeely ML, Karvinen KH, Wang Q, Courneya KS. Alberta physical activity and breast cancer prevention trial: sex hormone changes in a year-long exercise intervention among postmenopausal women. J Clin Oncol. 2010 Mar 20;28(9):1458-66. doi: 10.1200/JCO.2009.24.9557. Epub 2010 Feb 16.</citation>
    <PMID>20159820</PMID>
  </reference>
  <reference>
    <citation>Courneya KS, McKenzie DC, Mackey JR, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Vallerand JR, Adams SC, Proulx C, Dolan LB, Wooding E, Segal RJ. Subgroup effects in a randomised trial of different types and doses of exercise during breast cancer chemotherapy. Br J Cancer. 2014 Oct 28;111(9):1718-25. doi: 10.1038/bjc.2014.466. Epub 2014 Aug 21.</citation>
    <PMID>25144625</PMID>
  </reference>
  <reference>
    <citation>Edvardsen E, Hem E, Anderssen SA. End criteria for reaching maximal oxygen uptake must be strict and adjusted to sex and age: a cross-sectional study. PLoS One. 2014 Jan 14;9(1):e85276. doi: 10.1371/journal.pone.0085276. eCollection 2014.</citation>
    <PMID>24454832</PMID>
  </reference>
  <reference>
    <citation>Peel AB, Thomas SM, Dittus K, Jones LW, Lakoski SG. Cardiorespiratory fitness in breast cancer patients: a call for normative values. J Am Heart Assoc. 2014 Jan 13;3(1):e000432. doi: 10.1161/JAHA.113.000432.</citation>
    <PMID>24419734</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Inger Thune</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02240836/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02240836
org study id: 2014/945-1
nct id: NCT02240836
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise
      program comprised of strength and endurance training among newly diagnosed breast cancer
      patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims
      are to determine whether the 12 month exercise program will influence factors associated with
      metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer
      specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be
      assessed and evaluated.
The EBBA (Energy Balance and Breast cancer Aspects)-II study is a randomized clinical 12
      month physical activity intervention trial, including female breast cancer patients diagnosed
      with histologically verified invasive cancer stage I-II or carcinoma in situ (DCIS/LCIS)
      grade 3.

        -  Participants are randomized to either control or intervention group 10 days +/- 2 days
           after surgery. The intervention start 3 weeks after surgery and continue throughout
           adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). The
           intervention group receive a detailed training program based on their own ventilatory
           maximal oxygen consumption (VO2max) at baseline. They meet for supervised training
           sessions in groups for 60 minutes x 2/ week during 12 months. In addition, they are
           informed to exercise at home for at least of total 120 minutes weekly aiming to perform
           a total of 240 minutes exercise, weekly. The patients in the control group receive
           standard of care without any restrictions regarding exercise.

        -  All participants will undergo a series of measurements before surgery, after surgery, 6
           months and after the 12 months exercise intervention trial. Clinical measurements will
           include anthropometric measurements, fasting blood, fecal and urine samples and
           cardiopulmonary exercise test (CPET). Complete questionnaires (food diary (PFD)/food
           frequency questionnaires (FFQ), quality of life (QoL)).

        -  All participants will come to clinical examination and fasting blood sampling after 2,
           3, 5 and 10 years follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: VO2max
time frame: Baseline,12 months
description: Change in VO2max from baseline to 12 months
measure: BMI
time frame: Baseline,12 months
description: Change in BMI from baseline to 12 months
measure: Systolic blood pressure
time frame: Baseline,12 months
description: Change in systolic blood pressure from baseline to 12 months
measure: Diastolic blood pressure
time frame: Baseline,12 months
description: Change in diastolic blood pressure from baseline to 12 months
measure: Total cholesterol
time frame: Baseline,12 months
description: Change in total cholesterol from baseline to 12 months
measure: LDL cholesterol
time frame: Baseline,12 months
description: Change in LDL cholesterol from baseline to 12 months
measure: HDL cholesterol
time frame: Baseline,12 months
description: Change in HDL cholesterol from baseline to 12 months
measure: Total cholesterol/HDL cholesterol
time frame: Baseline,12 months
description: Change in total cholesterol/HDL cholesterol from baseline to 12 months
measure: HbA1c
time frame: Baseline,12 months
description: Change in concentrations of HbA1c from baseline to 12 months
measure: Insulin
time frame: Baseline,12 months
description: Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months
measure: Triglycerides
time frame: Baseline,12 months
description: Change in concentrations of triglycerides from baseline to 12 months
measure: C-reactive Protein (CRP)
time frame: Baseline,12 months
description: Change in concentrations of CRP (mg/L) from baseline to 12 months
measure: Heart rate
time frame: Baseline,12 months
description: Change in heart rate from baseline to 12 months
measure: Total fat
time frame: Baseline,12 months
description: Change in total fat from baseline to 12 months
measure: Truncated fat
time frame: Baseline,12 months
description: Change in truncated fat from baseline to 12 months
measure: Waist circumference
time frame: Baseline,12 months
description: Change in waist circumference from baseline to 12 months
measure: Energy from food diary
time frame: Baseline,12 months
description: Change in energy from food diary from baseline to 12 months
measure: Metabolic syndrome
time frame: 12 months
description: Dichotomous outcome (yes/no)
measure: Respiratory Quotient (RQ)
time frame: 12 months
description: Ratio between the amount of CO2 produced in metabolism and O2 used
measure: Lactate
time frame: 12 months
description: Blood lactate from fingertip one minute after test
measure: HRmax
time frame: 12 months
description: Maximal heart rate
measure: BORGmax
time frame: 12 months
description: Subjective measure of exhaustion
measure: Disease-free survival
time frame: Baseline, 1 year, 2 years, 5 years, 10 years
description: Time from baseline to the date of cancer symptoms or death
measure: Overall mortality
time frame: Baseline, 1 year, 2 years, 5 years, 10 years
description: Time from baseline until the date of death, regardless of the cause of death
measure: Breast cancer-specific mortality
time frame: Baseline, 1 year, 2 years, 5 years, 10 years
description: Time from baseline until the date of breast cancer-specific death
measure: Other exploratory
time frame: 12 months
description: Forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), diffusing capacity of the lung for carbon monoxide (DLco)
Inflammatory markers, prothrombotic markers, urinary markers, adipokines
Levels of sex steroid hormones
Growth factors (Insulin-like growth factor [IGF], insulin, insulin-like growth factor binding protein [IGFBP])
Microenvironment of the breast, tumor infiltrating lymphocytes (TILS), Crown like structures (CLS)
Microbiota
Quality of life and dietary factors
arm group label: Intervention. Exercise
arm group type: Experimental
description: The intervention starts 3-4 weeks after surgical treatment. The exercise program is performed in parallel with standard breast cancer treatment, and take place in supervised exercise groups by experienced physiotherapists. The duration of the intervention exercise program is 12 months, and the participants will attend the exercise groups for training 60 minutes twice a week. Additionally, they will exercise at home for at least 120 minutes a week, aiming to perform a total of 240 minutes of exercise per week
arm group label: Control group
arm group type: No Intervention
description: Control group, standard treatment regimen
intervention type: Other
intervention name: Intervention. Exercise
description: Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.
arm group label: Intervention. Exercise
other name: Physical activity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Inger Thune, MD. PhD
role: Principal Investigator
affiliation: The Department of Oncology, Ullevål, Oslo University Hospital
facility: 
facility: 
country: Norway
citation: Thune I, Njolstad I, Lochen ML, Forde OH. Physical activity improves the metabolic risk profiles in men and women: the Tromso Study. Arch Intern Med. 1998 Aug 10-24;158(15):1633-40. doi: 10.1001/archinte.158.15.1633. Erratum In: Arch Intern Med 1998 Jan 11;159(1):17.
PMID: 9701097
citation: Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. doi: 10.1001/jama.289.3.323.
PMID: 12525233
citation: Furberg AS, Veierod MB, Wilsgaard T, Bernstein L, Thune I. Serum high-density lipoprotein cholesterol, metabolic profile, and breast cancer risk. J Natl Cancer Inst. 2004 Aug 4;96(15):1152-60. doi: 10.1093/jnci/djh216.
PMID: 15292387
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responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Inger Thune
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Lobular
mesh term: Breast Carcinoma In Situ
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