<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/NCT03286257</url>
  </required_header>
  <id_info>
    <org_study_id>16/NW/0166</org_study_id>
    <nct_id>NCT03286257</nct_id>
  </id_info>
  <brief_title>Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?</brief_title>
  <official_title>Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool John Moores University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool John Moores University</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>
      In brief, this study sets out to understand if exercise training can reduce the frequency and&#xD;
      severity of hot flushes associated with breast cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In detail, the aim of this research project is to investigate whether improving temperature&#xD;
      control mechanisms including vascular function, with exercise training is beneficial in&#xD;
      alleviating hot flushes in breast cancer patients and their associated quality of life&#xD;
      symptoms. Participants will be recruited at least 3-months post breast cancer treatment&#xD;
      (surgery, radio-therapy, chemotherapy). This time point has been chosen for this study to&#xD;
      allow patients to fully engage in the exercise intervention following treatment. All&#xD;
      participants will be asked to attend the laboratory at Liverpool John Moores University on 4&#xD;
      separate occasions; 2 visits pre- and 2 visits following the exercise intervention for data&#xD;
      collection including measures of vascular health, physical activity, sedentary behaviour, and&#xD;
      fitness. The investigators will also gain information on food intake and incidence of hot&#xD;
      flushes across a 7-day period pre- and post the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Thermoregulation</measure>
    <time_frame>Change from pre- to post- 16 week exercise intervention</time_frame>
    <description>Participants will wear a tube-lined suit that allows manipulation of skin temperature by heating the water passed through the tubes. Core temperature will be increased by 1 degree (monitored using a temperature pill) with sweat rate and skin temperature recordings taken at 5minute intervals across 1 hour of heating. Thermoregulation will be compared during this hour to that of the post-exercise intervention re-test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Skin Blood Flow</measure>
    <time_frame>Change from pre- to post- 16 week exercise intervention</time_frame>
    <description>The change in skin blood flow will be measured using laser Doppler probes at the forearm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cerebral Blood Flow</measure>
    <time_frame>Change from pre- to post- 16 week exercise intervention</time_frame>
    <description>Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vascular Function</measure>
    <time_frame>Change from pre- to post- 16 week exercise intervention</time_frame>
    <description>Vascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vascular Structure</measure>
    <time_frame>Change from pre- to post- 16 week exercise intervention</time_frame>
    <description>Vascular structure will be measured at the carotid artery using ultrasound imaging to clearly visualise the artery. The image will be adjusted so artery wall thickness can be clearly seen with a 30 second recording taken at 3 different angles. The average of the three angles will be calculated with results reported as change in millimetres.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete a partially supervised 4 month exercise program consisting of 3-5 sessions/week at a moderate intensity (40-75% heart rate (HR) reserve) at Liverpool Lifestyles gyms. Participants will be given free access to the Wellness Key System© when using the Lifestyles exercise equipment which allows researchers to remotely track the exercise intensity of participants accurately.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Pre-menopausal, Peri-menopausal or post-menopausal&#xD;
&#xD;
          -  &gt;4 hot flushes per day&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Treated with tamoxifen or aromatase inhibitor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled or severe hypertension (blood pressure &gt; 160/100 mm Hg)&#xD;
&#xD;
          -  Any previous injury preventing exercise&#xD;
&#xD;
          -  Type 1 or 2 diabetes&#xD;
&#xD;
          -  Anti-depressants&#xD;
&#xD;
          -  Currently undergoing chemotherapy or radiotherapy&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Cannot readily read and understand English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Jones</last_name>
    <role>Study Director</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Helen Jones, Professor</last_name>
    <phone>0151 904 6270</phone>
    <email>H.Jones1@ljmu.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aine Brislane, MSc</last_name>
    <phone>0151 904 6278</phone>
    <email>a.brislane@2016.ljmu.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Research Institute for Sport and Exercise Sciences (RISES)</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L33AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helen Jones, Professor</last_name>
      <phone>01519046270</phone>
      <email>H.Jones1@ljmu.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Aine Brislane, MSc</last_name>
      <phone>01519046278</phone>
      <email>a.brislane@2016.ljmu.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Liverpool John Moores University</investigator_affiliation>
    <investigator_full_name>Áine Brislane</investigator_full_name>
    <investigator_title>Principle Investigator Áine Brislane</investigator_title>
  </responsible_party>
  <keyword>Vascular function</keyword>
  <keyword>Vascular structure</keyword>
  <keyword>Thermoregulation</keyword>
  <keyword>Hot flushes</keyword>
  <keyword>Cerebral blood flow</keyword>
  <keyword>Exercise training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Hot Flashes</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/NCT03286257
org study id: 16/NW/0166
nct id: NCT03286257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In brief, this study sets out to understand if exercise training can reduce the frequency and
      severity of hot flushes associated with breast cancer treatment.
In detail, the aim of this research project is to investigate whether improving temperature
      control mechanisms including vascular function, with exercise training is beneficial in
      alleviating hot flushes in breast cancer patients and their associated quality of life
      symptoms. Participants will be recruited at least 3-months post breast cancer treatment
      (surgery, radio-therapy, chemotherapy). This time point has been chosen for this study to
      allow patients to fully engage in the exercise intervention following treatment. All
      participants will be asked to attend the laboratory at Liverpool John Moores University on 4
      separate occasions; 2 visits pre- and 2 visits following the exercise intervention for data
      collection including measures of vascular health, physical activity, sedentary behaviour, and
      fitness. The investigators will also gain information on food intake and incidence of hot
      flushes across a 7-day period pre- and post the intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Thermoregulation
time frame: Change from pre- to post- 16 week exercise intervention
description: Participants will wear a tube-lined suit that allows manipulation of skin temperature by heating the water passed through the tubes. Core temperature will be increased by 1 degree (monitored using a temperature pill) with sweat rate and skin temperature recordings taken at 5minute intervals across 1 hour of heating. Thermoregulation will be compared during this hour to that of the post-exercise intervention re-test.
measure: Change in Skin Blood Flow
time frame: Change from pre- to post- 16 week exercise intervention
description: The change in skin blood flow will be measured using laser Doppler probes at the forearm.
measure: Change in Cerebral Blood Flow
time frame: Change from pre- to post- 16 week exercise intervention
description: Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.
measure: Change in Vascular Function
time frame: Change from pre- to post- 16 week exercise intervention
description: Vascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change.
measure: Change in Vascular Structure
time frame: Change from pre- to post- 16 week exercise intervention
description: Vascular structure will be measured at the carotid artery using ultrasound imaging to clearly visualise the artery. The image will be adjusted so artery wall thickness can be clearly seen with a 30 second recording taken at 3 different angles. The average of the three angles will be calculated with results reported as change in millimetres.
arm group label: Exercise Intervention
arm group type: Experimental
description: Participants will complete a partially supervised 4 month exercise program consisting of 3-5 sessions/week at a moderate intensity (40-75% heart rate (HR) reserve) at Liverpool Lifestyles gyms. Participants will be given free access to the Wellness Key System© when using the Lifestyles exercise equipment which allows researchers to remotely track the exercise intensity of participants accurately.
intervention type: Behavioral
intervention name: Exercise Intervention
description: A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.
arm group label: Exercise Intervention
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Helen Jones
role: Study Director
affiliation: Professor
last name: Helen Jones, Professor
phone: 0151 904 6270
email: H.Jones1@ljmu.ac.uk
last name: Aine Brislane, MSc
phone: 0151 904 6278
email: a.brislane@2016.ljmu.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Liverpool John Moores University
investigator full name: Áine Brislane
investigator title: Principle Investigator Áine Brislane
mesh term: Breast Neoplasms
mesh term: Hot Flashes
sharing ipd: No