<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/NCT03795493</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA.CC-18-0657</org_study_id>
    <nct_id>NCT03795493</nct_id>
  </id_info>
  <brief_title>Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer</brief_title>
  <acronym>DREAM</acronym>
  <official_title>Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</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>University of Alberta</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>
      Fifty patients with metastatic breast cancer will be randomly assigned to an acute&#xD;
      intervention consisting of both aerobic exercise and caloric restriction administered acutely&#xD;
      prior to each of six chemotherapy cycles, or to usual care. The aerobic exercise intervention&#xD;
      will consist of a single supervised recumbent cycle ergometer session performed concurrent to&#xD;
      each chemotherapy infusion. The diet intervention consists of provision of meals freshly&#xD;
      prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy&#xD;
      requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy&#xD;
      infusion. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of&#xD;
      tumor regression), while treatment side effects will be assessed by MRI and treatment&#xD;
      symptoms and quality of life will be assessed via questionnaire before, during and after up&#xD;
      to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall&#xD;
      survival will be tracked for two years after diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite major advances in recent decades in treatment for early stage breast cancer leading&#xD;
      to an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to&#xD;
      resistance to most available treatments. As such, 5-year survival rate for metastatic breast&#xD;
      cancer is only 22%. One mechanism for resistance to cancer therapies and promotion of&#xD;
      metastasis in solid tumors is that their vascular system is impaired causing diminished&#xD;
      delivery of systemic therapy and oxygen. Furthermore, toxicity can be quite high with&#xD;
      metastatic regimens, which can limit the dose received. Both diet and exercise have been used&#xD;
      to attenuate treatment toxicity, but the promising preclinical evidence showing their&#xD;
      potential to enhance chemotherapy efficacy and survival has not been studied in humans. For&#xD;
      example, a single bout of aerobic exercise substantially increased tumor blood flow and&#xD;
      oxygen delivery, suggesting that chemotherapy delivery to the tumor would be enhanced. Short&#xD;
      periods of fasting or caloric restriction also appear to be safe and effective strategies to&#xD;
      inhibit tumor growth and enhance chemotherapy efficacy, while also promoting resistance to&#xD;
      chemotherapy in healthy cells. Furthermore, combining aerobic exercise and caloric&#xD;
      restriction can elicit synergistic effects on outcomes relevant to cancer, including body&#xD;
      composition, aerobic fitness, fasting insulin and glucose, insulin-like growth factor, and&#xD;
      tumor promoter pathways.&#xD;
&#xD;
      Study Design: With preclinical proof-of-principle and clinical safety and feasibility of each&#xD;
      intervention independently established, this study will be a phase II, two-arm, single blind,&#xD;
      randomized controlled trial. Fifty patients will be randomly assigned to an acute&#xD;
      intervention consisting of both caloric restriction administered acutely prior to and aerobic&#xD;
      exercise during each treatment of six chemotherapy cycles, or to usual care.&#xD;
&#xD;
      Approach: Participants will include adults with metastatic breast cancer with measurable&#xD;
      metastases that will receive intravenous chemotherapy. The aerobic exercise intervention will&#xD;
      consist of a single supervised recumbent cycle ergometer session performed concurrent to each&#xD;
      chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared&#xD;
      in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements&#xD;
      and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. The diet&#xD;
      period will be reduced from 72 to 48 hours when there are &lt;7 days between infusions (ie&#xD;
      weekly protocols) to avoid inducing a sustained caloric deficit leading to weight loss. This&#xD;
      acute intervention does not lead to long-term nutritional imbalances. Exercise intensity and&#xD;
      meals will be individualized to participant abilities and preferences. All participants,&#xD;
      regardless of group assignment, will receive a one-time phone consultation with a registered&#xD;
      dietitian and a certified exercise physiologist to enhance recruitment and retention. Tumor&#xD;
      outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor&#xD;
      regression), while treatment side effects will be assessed by MRI and treatment symptoms and&#xD;
      quality of life will be assessed via questionnaire before, during and after up to six&#xD;
      chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival&#xD;
      will be tracked for two years after diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor size change after 6 cycles (mm)</measure>
    <time_frame>0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Change in tumor size measured by computerized tomography after 6 cycles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response to therapy by magnetic resonance imaging (mm²/s)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Magnetic resonance imaging (MRI) derived water apparent diffusion coefficient within the tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor size change after 3 cycles (mm)</measure>
    <time_frame>0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle</time_frame>
    <description>Change in tumor size measured by computerized tomography after 3 cycles.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Left ventricular ejection fraction (%)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>MRI-derived left ventricular ejection fraction</description>
  </other_outcome>
  <other_outcome>
    <measure>Left ventricular global longitudinal strain (%)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>MRI-derived left ventricular global longitudinal strain</description>
  </other_outcome>
  <other_outcome>
    <measure>Left ventricular mass (g/m²)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>MRI-derived left ventricular mass</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver fat fraction (%)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Percent of fat in liver derived by PROFIT1 chemical-shift encoded MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver T1 relaxation time (ms)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>MRI-derived relaxation time from healthy liver</description>
  </other_outcome>
  <other_outcome>
    <measure>Thigh skeletal muscle T1 relaxation time (ms)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>MRI-derived skeletal muscle T1 relaxation time at mid-thigh</description>
  </other_outcome>
  <other_outcome>
    <measure>Thigh muscle volume (mL)</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>PROFIT1 chemical-shift encoded MRI of the mid-thigh will be used to assess thigh muscle volume</description>
  </other_outcome>
  <other_outcome>
    <measure>Thigh skeletal muscle fat fraction %</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Percent of intermuscular fat in thigh muscle derived by PROFIT1 chemical-shift encoded MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-reported treatment symptoms</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle, at each chemotherapy treatment, and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Patient-reported treatment symptoms assessed using the Rotterdam Symptom Checklist</description>
  </other_outcome>
  <other_outcome>
    <measure>Self reported quality of life</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Quality of life assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a better quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue</measure>
    <time_frame>0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle</time_frame>
    <description>Fatigue assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a lower level of fatigue.</description>
  </other_outcome>
  <other_outcome>
    <measure>Progression-free survival (months)</measure>
    <time_frame>Two years after study enrollment</time_frame>
    <description>Progression-free survival time extracted from Cancer Control Alberta's electronic database</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall survival (months)</measure>
    <time_frame>Two years after study enrollment</time_frame>
    <description>Overall survival time extracted from Cancer Control Alberta's electronic database</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard chemotherapy treatment and oncology care plus short-term diet and exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard chemotherapy treatment and oncology care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short-term diet and exercise intervention</intervention_name>
    <description>Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stage IV or metastatic breast cancer;&#xD;
&#xD;
          -  Measurable metastases.&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  Starting (or having only received one treatment of) any type of intravenously&#xD;
             administered chemotherapy;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Score &lt; 3&#xD;
&#xD;
          -  Oncologist approval to participate&#xD;
&#xD;
          -  Able to communicate and read and understand English;&#xD;
&#xD;
          -  Willing and able to adhere to the study interventions and assessments;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limitations to sustained exercise (including bone metastases in the femur neck);&#xD;
&#xD;
          -  Clinical evidence of cachexia (oncologist's discretion, study team will use body mass&#xD;
             index &lt;18.5kg/m² as a flag to highlight concern to treating oncologist);&#xD;
&#xD;
          -  Body mass &gt;109 kg at time of enrollment;&#xD;
&#xD;
          -  Diabetes;&#xD;
&#xD;
          -  Severe food allergies;&#xD;
&#xD;
          -  History of eating disorder (diagnosed or self-reported);&#xD;
&#xD;
          -  Strict diet restrictions including vegetarian or vegan;&#xD;
&#xD;
          -  Unable to provide informed consent (i.e. cognitive impairment);&#xD;
&#xD;
          -  Supplemental oxygen requirement;&#xD;
&#xD;
          -  Uncontrolled pleural effusions (oncologists approval if pleural effusions exists and&#xD;
             are controlled);&#xD;
&#xD;
          -  Bilirubin &gt;30 umol/L;&#xD;
&#xD;
          -  Creatinine &gt;120 umol/L;&#xD;
&#xD;
          -  Pregnant;&#xD;
&#xD;
          -  Contraindications to 3T MRI for research purposes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla Prado, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Thompson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Caloric Restriction</keyword>
  <keyword>Chemotherapy</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/NCT03795493
org study id: HREBA.CC-18-0657
nct id: NCT03795493
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fifty patients with metastatic breast cancer will be randomly assigned to an acute
      intervention consisting of both aerobic exercise and caloric restriction administered acutely
      prior to each of six chemotherapy cycles, or to usual care. The aerobic exercise intervention
      will consist of a single supervised recumbent cycle ergometer session performed concurrent to
      each chemotherapy infusion. The diet intervention consists of provision of meals freshly
      prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy
      requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy
      infusion. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of
      tumor regression), while treatment side effects will be assessed by MRI and treatment
      symptoms and quality of life will be assessed via questionnaire before, during and after up
      to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall
      survival will be tracked for two years after diagnosis.
Despite major advances in recent decades in treatment for early stage breast cancer leading
      to an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to
      resistance to most available treatments. As such, 5-year survival rate for metastatic breast
      cancer is only 22%. One mechanism for resistance to cancer therapies and promotion of
      metastasis in solid tumors is that their vascular system is impaired causing diminished
      delivery of systemic therapy and oxygen. Furthermore, toxicity can be quite high with
      metastatic regimens, which can limit the dose received. Both diet and exercise have been used
      to attenuate treatment toxicity, but the promising preclinical evidence showing their
      potential to enhance chemotherapy efficacy and survival has not been studied in humans. For
      example, a single bout of aerobic exercise substantially increased tumor blood flow and
      oxygen delivery, suggesting that chemotherapy delivery to the tumor would be enhanced. Short
      periods of fasting or caloric restriction also appear to be safe and effective strategies to
      inhibit tumor growth and enhance chemotherapy efficacy, while also promoting resistance to
      chemotherapy in healthy cells. Furthermore, combining aerobic exercise and caloric
      restriction can elicit synergistic effects on outcomes relevant to cancer, including body
      composition, aerobic fitness, fasting insulin and glucose, insulin-like growth factor, and
      tumor promoter pathways.

      Study Design: With preclinical proof-of-principle and clinical safety and feasibility of each
      intervention independently established, this study will be a phase II, two-arm, single blind,
      randomized controlled trial. Fifty patients will be randomly assigned to an acute
      intervention consisting of both caloric restriction administered acutely prior to and aerobic
      exercise during each treatment of six chemotherapy cycles, or to usual care.

      Approach: Participants will include adults with metastatic breast cancer with measurable
      metastases that will receive intravenous chemotherapy. The aerobic exercise intervention will
      consist of a single supervised recumbent cycle ergometer session performed concurrent to each
      chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared
      in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements
      and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. The diet
      period will be reduced from 72 to 48 hours when there are <7 days between infusions (ie
      weekly protocols) to avoid inducing a sustained caloric deficit leading to weight loss. This
      acute intervention does not lead to long-term nutritional imbalances. Exercise intensity and
      meals will be individualized to participant abilities and preferences. All participants,
      regardless of group assignment, will receive a one-time phone consultation with a registered
      dietitian and a certified exercise physiologist to enhance recruitment and retention. Tumor
      outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor
      regression), while treatment side effects will be assessed by MRI and treatment symptoms and
      quality of life will be assessed via questionnaire before, during and after up to six
      chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival
      will be tracked for two years after diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Tumor size change after 6 cycles (mm)
time frame: 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle
description: Change in tumor size measured by computerized tomography after 6 cycles.
measure: Tumor response to therapy by magnetic resonance imaging (mm²/s)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Magnetic resonance imaging (MRI) derived water apparent diffusion coefficient within the tumor
measure: Tumor size change after 3 cycles (mm)
time frame: 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle
description: Change in tumor size measured by computerized tomography after 3 cycles.
measure: Left ventricular ejection fraction (%)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: MRI-derived left ventricular ejection fraction
measure: Left ventricular global longitudinal strain (%)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: MRI-derived left ventricular global longitudinal strain
measure: Left ventricular mass (g/m²)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: MRI-derived left ventricular mass
measure: Liver fat fraction (%)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Percent of fat in liver derived by PROFIT1 chemical-shift encoded MRI
measure: Liver T1 relaxation time (ms)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: MRI-derived relaxation time from healthy liver
measure: Thigh skeletal muscle T1 relaxation time (ms)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: MRI-derived skeletal muscle T1 relaxation time at mid-thigh
measure: Thigh muscle volume (mL)
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: PROFIT1 chemical-shift encoded MRI of the mid-thigh will be used to assess thigh muscle volume
measure: Thigh skeletal muscle fat fraction %
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Percent of intermuscular fat in thigh muscle derived by PROFIT1 chemical-shift encoded MRI
measure: Patient-reported treatment symptoms
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle, at each chemotherapy treatment, and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Patient-reported treatment symptoms assessed using the Rotterdam Symptom Checklist
measure: Self reported quality of life
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Quality of life assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a better quality of life.
measure: Fatigue
time frame: 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle
description: Fatigue assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a lower level of fatigue.
measure: Progression-free survival (months)
time frame: Two years after study enrollment
description: Progression-free survival time extracted from Cancer Control Alberta's electronic database
measure: Overall survival (months)
time frame: Two years after study enrollment
description: Overall survival time extracted from Cancer Control Alberta's electronic database
arm group label: Intervention Group
arm group type: Experimental
description: Standard chemotherapy treatment and oncology care plus short-term diet and exercise intervention.
arm group label: Control Group
arm group type: No Intervention
description: Standard chemotherapy treatment and oncology care.
intervention type: Behavioral
intervention name: Short-term diet and exercise intervention
description: Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carla Prado, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Richard Thompson, PhD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided