<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/NCT03748550</url>
  </required_header>
  <id_info>
    <org_study_id>1024489</org_study_id>
    <secondary_id>1024489</secondary_id>
    <nct_id>NCT03748550</nct_id>
  </id_info>
  <brief_title>Exercise to Prevent AnthraCycline-based Cardio-Toxicity Study 2.0 (EXACT2)</brief_title>
  <acronym>EXACT 2</acronym>
  <official_title>EXercise to Prevent AnthraCycline-based Cardio-Toxicity 2.0 (EXACT2) in Individuals With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Cancer Society (CCS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      Although great progress has been made in treating breast cancer, long-term health may be&#xD;
      impaired by cancer therapy. For example, some chemotherapy drugs (e.g., anthracyclines) are&#xD;
      known to cause declines in heart health. While the impact can vary, some will experience&#xD;
      substantial heart damage that may lead to heart failure and death. As these treatments are&#xD;
      highly effective, there is a need to find ways to reduce the damaging effects while not&#xD;
      interfering with its anticancer potential. As it is well-known that regular exercise can&#xD;
      improve heart health, the purpose of this study is to explore the role of exercise as a heart&#xD;
      protective therapy for breast cancer patients receiving heart damaging chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a result of advances in cancer treatment, the number of breast cancer (BC) survivors is&#xD;
      increasing in Canada. Unfortunately, the drugs used to treat BC can have a negative impact on&#xD;
      the long term health and welfare of the BC survivors (BCS). For example, commonly used cancer&#xD;
      therapies, such as anthracyclines (AC) are known to cause declines in heart health. While the&#xD;
      impact can vary, some individuals treated with these medications will experience substantial&#xD;
      heart damage that may lead to heart failure and death. As a result, risk of cardiovascular&#xD;
      morbidity/mortality has become a major concern for BCS that received AC treatment. As a&#xD;
      result, there is an immediate need to find therapies that can be used to prevent damage to&#xD;
      the heart without limiting the anticancer potential of AC.&#xD;
&#xD;
      A growing body of evidence suggests that aerobic exercise training may help protect the heart&#xD;
      against the damaging effects of AC therapy. These studies, which were conducted using animal&#xD;
      models, have shown that performing aerobic exercise before or while undergoing AC therapy&#xD;
      helps to maintain heart function and prevent structural changes in the heart. However, to the&#xD;
      author's knowledge similar studies have not been conducted in BCS undergoing treatment, thus&#xD;
      it remains unclear whether exercise has the same cardioprotective effect in BCS. As a first&#xD;
      step in answering this question, our research group conducted a pilot study that showed a&#xD;
      12-week aerobic exercise program is safe and feasible for BCS undergoing chemotherapy. The&#xD;
      next step in our research is to determine whether aerobic exercise decreases or prevents&#xD;
      cardiotoxicity in BCS receiving AC treatment. Therefore, the purpose of this study is to&#xD;
      determine whether a 12-week home based aerobic exercise program mitigates AC-mediated&#xD;
      cardiotoxicity in BCS on active treatment. The specific objectives of the study are to&#xD;
      determine whether the aerobic exercise program: 1) prevents structural and functional changes&#xD;
      in the heart; 2) maintains peak aerobic capacity throughout the treatment process; and 3)&#xD;
      decreases biological markers associated with heart damage.&#xD;
&#xD;
      This is a randomized control trial with repeated measures. BCSs will be randomly assigned to&#xD;
      either the wait-list control (CTL) group (standard of care (SOC) or the aerobic exercise&#xD;
      (AEX; SOC + 12-week home-based aerobic exercise program). One hundred BCS (18-65 years of&#xD;
      age) on AC treatment will be recruited from two sites, Halifax, NS (n=50) and Winnipeg, MB&#xD;
      (n=50). Patients in the AEX group will perform two exercise sessions per week that will range&#xD;
      from low intensity (~45 min) to vigorous intensity (~20 min). BCS will monitor their exercise&#xD;
      intensity with Polar A370 HR monitors, which they will be given for the duration of the&#xD;
      study.The primary outcome measure for the study is cardiac function as determined by&#xD;
      echocardiography and a cardiac stress test. Secondary outcome measures include serum&#xD;
      biomarkers associated with cardiotoxicity (e.g. c-reactive protein, hsTNT, NT-proBNP).&#xD;
      Patient-reported outcomes including levels of fatigue and quality of life will also be&#xD;
      assessed. The study outcome measures will be assessed prior to the participants starting AC&#xD;
      therapy (week-0), post-exercise intervention (week-12) and 6 months after the completion of&#xD;
      the AEX. Of note, upon completion of the 6 month follow-up testing participants in the CTL&#xD;
      group, if interested, will be given the home-based AEX as well the necessary support to&#xD;
      complete the program.&#xD;
&#xD;
      This research will provide the first direct evidence that aerobic exercise protects the heart&#xD;
      from AC-mediated damage in BCS undergoing cancer treatment. Both the medical and research&#xD;
      communities will benefit from this research as it could lead to the improvement of long term&#xD;
      health of cancer survivorship as well as improve the understanding of how the heart health&#xD;
      can be maintained during cancer therapy. Given the significant impact of AC therapy on&#xD;
      improving BC prognosis, and the potential protective effects of exercise training, this study&#xD;
      will be important in improving BC care via the improvement of the quality of life and&#xD;
      increased survivorship.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Participants will be randomly allocated to either the standard of care group (control) or the intervention group (standard of care + 12-weeks aerobic exercise).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Clinicians interpreting the echocardiograms and stress test results will not know whether the participant is in the control group or the exercise intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Left Ventricular (LV) Function</measure>
    <time_frame>LV function will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>LV function will be assessed using serial transthoracic echocardiography (TTE) as well as tissue velocity imaging (TVI) and strain imaging (SI.) For 2-dimensional (2D) LV cavity dimensions and LVEF will be determined from the acquired 2D images according to established criteria. Tissue Doppler-derived indexes will be recorded at the base of the lateral mitral annuli to determine longitudinal endocardial velocities. The indexes that will be assessed are systolic (S'), early diastolic (e') and late diastolic (a') velocities. Doppler-independent strain will be assessed offline using semi-automated speckle tracking techniques. These will be performed using parasternal and apical views to determine both global longitudinal and radial strain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiac Electrical Activity</measure>
    <time_frame>The cardiac ECG will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>Cardiac electrocardiogram at rest will be assessed using a 12 lead ECG (General Electric Case System). Specifically, the duration (ms) of the PR interval, RR interval, QRS interval and QT interval will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aerobic Fitness</measure>
    <time_frame>Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>Cardiac Stress Tests results will be used to predict peak oxygen consumption (ml/kg/min). In brief, participants will perform a graded exercise test until they reach volitional fatigue or the test is terminated due to adverse physiological changes. Predictive equations will then be used to predict the participant's peak oxygen uptake based on the total duration (seconds) of the treadmill test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood biomarkers</measure>
    <time_frame>Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>Venipuncture will be performed by a nurse/phlebotomist to collect blood samples which will be used to quantify systemic levels of c-reactive protein (CRP), high sensitivity troponin (hs-TNT) and NTproBNP levels. Upon collection, blood samples will be processed, and the serum will be extracted and stored at -20°C until it is required for analysis. CRP, hs-TNT and N-terminal pro b-type natriuretic peptide (NTproBNP) levels will be assessed using commercially available ELISA kits. All biomarkers will be measured in pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Assessment for Cancer Therapy</measure>
    <time_frame>Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>The Functional Assessment for Cancer Therapy survey for patients with breast cancer (FACT-B) will be used to assess quality of life. The FACT-B includes sub-scales for assessing physical, social/family, emotional, and functional well-being. FACT-B total score ranges from 0-148.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue</measure>
    <time_frame>Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.</time_frame>
    <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13 item questionnaire (maximum score =160) that will be used to assess cancer-related fatigue. Higher scores are indicative of higher levels of fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cancer, Breast</condition>
  <condition>Cardiotoxicity</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard of care treatment for their breast cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>All participants will receive standard of care for their cancer as well as given a 12-week, home-based progressive aerobic exercise (AE) program. A nonlinear progressive training approach will be used whereby each participant will perform two AE sessions (e.g. walking), on non-consecutive days, per week. AE sessions will vary between low (35-45% heart rate reserve (HRR)), low-moderate (46-55% HRR), high-moderate (56-70% HRR) and high (71-85% HRR) intensity.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) must be 18 years or older.&#xD;
&#xD;
          -  diagnosed with breast cancer (stages I-III) and not have started therapy.&#xD;
&#xD;
          -  must be scheduled to receive AC- based chemotherapy (minimum dose of 240 mg/m2 of DOX&#xD;
             or 300 mg/m2 of DAN).&#xD;
&#xD;
          -  are able to undertake a 12-week home-based, progressive aerobic exercise program.&#xD;
&#xD;
          -  have medical clearance from a cardiologist (e.g. based on stress test results) to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant cognitive limitations.&#xD;
&#xD;
          -  pre-existing medical condition that would otherwise contraindicate aerobic exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Scott A Grandy, PhD</last_name>
    <phone>902-494-4303</phone>
    <email>scott.grandy@dal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melanie R Keats, PhD</last_name>
    <phone>902-494-7173</phone>
    <email>melanie.keats@dal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Boniface Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Davinder S Jassal, MD</last_name>
      <phone>204-233-8563</phone>
      <email>djassal@sbgh.mb.ca</email>
    </contact>
    <investigator>
      <last_name>Davinder S Jassal, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thang Nguyen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott A Grandy, PhD</last_name>
      <phone>902-494-4303</phone>
      <email>scott.grandy@dal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Melanie R Keats, PhD</last_name>
      <phone>902-494-7173</phone>
      <email>melanie.keats@dal.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Scott A Grandy, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Melanie R Keats, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tallal Younis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicholas Giacomantonio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Scott Grandy</investigator_full_name>
    <investigator_title>Affiliate Scientist Cardiology</investigator_title>
  </responsible_party>
  <keyword>Anthracyclines</keyword>
  <keyword>Cardiotoxic</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Aerobic exercise</keyword>
  <keyword>Cardiac structure</keyword>
  <keyword>Cardiac function</keyword>
  <keyword>CVD risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Cardiotoxicity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03748550
org study id: 1024489
secondary id: 1024489
nct id: NCT03748550
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although great progress has been made in treating breast cancer, long-term health may be
      impaired by cancer therapy. For example, some chemotherapy drugs (e.g., anthracyclines) are
      known to cause declines in heart health. While the impact can vary, some will experience
      substantial heart damage that may lead to heart failure and death. As these treatments are
      highly effective, there is a need to find ways to reduce the damaging effects while not
      interfering with its anticancer potential. As it is well-known that regular exercise can
      improve heart health, the purpose of this study is to explore the role of exercise as a heart
      protective therapy for breast cancer patients receiving heart damaging chemotherapy.
As a result of advances in cancer treatment, the number of breast cancer (BC) survivors is
      increasing in Canada. Unfortunately, the drugs used to treat BC can have a negative impact on
      the long term health and welfare of the BC survivors (BCS). For example, commonly used cancer
      therapies, such as anthracyclines (AC) are known to cause declines in heart health. While the
      impact can vary, some individuals treated with these medications will experience substantial
      heart damage that may lead to heart failure and death. As a result, risk of cardiovascular
      morbidity/mortality has become a major concern for BCS that received AC treatment. As a
      result, there is an immediate need to find therapies that can be used to prevent damage to
      the heart without limiting the anticancer potential of AC.

      A growing body of evidence suggests that aerobic exercise training may help protect the heart
      against the damaging effects of AC therapy. These studies, which were conducted using animal
      models, have shown that performing aerobic exercise before or while undergoing AC therapy
      helps to maintain heart function and prevent structural changes in the heart. However, to the
      author's knowledge similar studies have not been conducted in BCS undergoing treatment, thus
      it remains unclear whether exercise has the same cardioprotective effect in BCS. As a first
      step in answering this question, our research group conducted a pilot study that showed a
      12-week aerobic exercise program is safe and feasible for BCS undergoing chemotherapy. The
      next step in our research is to determine whether aerobic exercise decreases or prevents
      cardiotoxicity in BCS receiving AC treatment. Therefore, the purpose of this study is to
      determine whether a 12-week home based aerobic exercise program mitigates AC-mediated
      cardiotoxicity in BCS on active treatment. The specific objectives of the study are to
      determine whether the aerobic exercise program: 1) prevents structural and functional changes
      in the heart; 2) maintains peak aerobic capacity throughout the treatment process; and 3)
      decreases biological markers associated with heart damage.

      This is a randomized control trial with repeated measures. BCSs will be randomly assigned to
      either the wait-list control (CTL) group (standard of care (SOC) or the aerobic exercise
      (AEX; SOC + 12-week home-based aerobic exercise program). One hundred BCS (18-65 years of
      age) on AC treatment will be recruited from two sites, Halifax, NS (n=50) and Winnipeg, MB
      (n=50). Patients in the AEX group will perform two exercise sessions per week that will range
      from low intensity (~45 min) to vigorous intensity (~20 min). BCS will monitor their exercise
      intensity with Polar A370 HR monitors, which they will be given for the duration of the
      study.The primary outcome measure for the study is cardiac function as determined by
      echocardiography and a cardiac stress test. Secondary outcome measures include serum
      biomarkers associated with cardiotoxicity (e.g. c-reactive protein, hsTNT, NT-proBNP).
      Patient-reported outcomes including levels of fatigue and quality of life will also be
      assessed. The study outcome measures will be assessed prior to the participants starting AC
      therapy (week-0), post-exercise intervention (week-12) and 6 months after the completion of
      the AEX. Of note, upon completion of the 6 month follow-up testing participants in the CTL
      group, if interested, will be given the home-based AEX as well the necessary support to
      complete the program.

      This research will provide the first direct evidence that aerobic exercise protects the heart
      from AC-mediated damage in BCS undergoing cancer treatment. Both the medical and research
      communities will benefit from this research as it could lead to the improvement of long term
      health of cancer survivorship as well as improve the understanding of how the heart health
      can be maintained during cancer therapy. Given the significant impact of AC therapy on
      improving BC prognosis, and the potential protective effects of exercise training, this study
      will be important in improving BC care via the improvement of the quality of life and
      increased survivorship.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly allocated to either the standard of care group (control) or the intervention group (standard of care + 12-weeks aerobic exercise).
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Clinicians interpreting the echocardiograms and stress test results will not know whether the participant is in the control group or the exercise intervention.
measure: Change in Left Ventricular (LV) Function
time frame: LV function will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: LV function will be assessed using serial transthoracic echocardiography (TTE) as well as tissue velocity imaging (TVI) and strain imaging (SI.) For 2-dimensional (2D) LV cavity dimensions and LVEF will be determined from the acquired 2D images according to established criteria. Tissue Doppler-derived indexes will be recorded at the base of the lateral mitral annuli to determine longitudinal endocardial velocities. The indexes that will be assessed are systolic (S'), early diastolic (e') and late diastolic (a') velocities. Doppler-independent strain will be assessed offline using semi-automated speckle tracking techniques. These will be performed using parasternal and apical views to determine both global longitudinal and radial strain.
measure: Change in Cardiac Electrical Activity
time frame: The cardiac ECG will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: Cardiac electrocardiogram at rest will be assessed using a 12 lead ECG (General Electric Case System). Specifically, the duration (ms) of the PR interval, RR interval, QRS interval and QT interval will be determined.
measure: Change in Aerobic Fitness
time frame: Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: Cardiac Stress Tests results will be used to predict peak oxygen consumption (ml/kg/min). In brief, participants will perform a graded exercise test until they reach volitional fatigue or the test is terminated due to adverse physiological changes. Predictive equations will then be used to predict the participant's peak oxygen uptake based on the total duration (seconds) of the treadmill test.
measure: Change in Blood biomarkers
time frame: Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: Venipuncture will be performed by a nurse/phlebotomist to collect blood samples which will be used to quantify systemic levels of c-reactive protein (CRP), high sensitivity troponin (hs-TNT) and NTproBNP levels. Upon collection, blood samples will be processed, and the serum will be extracted and stored at -20°C until it is required for analysis. CRP, hs-TNT and N-terminal pro b-type natriuretic peptide (NTproBNP) levels will be assessed using commercially available ELISA kits. All biomarkers will be measured in pg/ml.
measure: Change in Functional Assessment for Cancer Therapy
time frame: Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: The Functional Assessment for Cancer Therapy survey for patients with breast cancer (FACT-B) will be used to assess quality of life. The FACT-B includes sub-scales for assessing physical, social/family, emotional, and functional well-being. FACT-B total score ranges from 0-148.
measure: Change in Fatigue
time frame: Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.
description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13 item questionnaire (maximum score =160) that will be used to assess cancer-related fatigue. Higher scores are indicative of higher levels of fatigue.
arm group label: Control
arm group type: No Intervention
description: Participants will receive standard of care treatment for their breast cancer.
arm group label: Exercise
arm group type: Experimental
description: Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.
intervention type: Behavioral
intervention name: Aerobic exercise
description: All participants will receive standard of care for their cancer as well as given a 12-week, home-based progressive aerobic exercise (AE) program. A nonlinear progressive training approach will be used whereby each participant will perform two AE sessions (e.g. walking), on non-consecutive days, per week. AE sessions will vary between low (35-45% heart rate reserve (HRR)), low-moderate (46-55% HRR), high-moderate (56-70% HRR) and high (71-85% HRR) intensity.
arm group label: Exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott A Grandy, PhD
phone: 902-494-4303
email: scott.grandy@dal.ca
last name: Melanie R Keats, PhD
phone: 902-494-7173
email: melanie.keats@dal.ca
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Scott Grandy
investigator title: Affiliate Scientist Cardiology
mesh term: Breast Neoplasms
mesh term: Cardiovascular Diseases
mesh term: Cardiotoxicity
sharing ipd: No