<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/NCT04416087</url>
  </required_header>
  <id_info>
    <org_study_id>T148/2020</org_study_id>
    <nct_id>NCT04416087</nct_id>
  </id_info>
  <brief_title>Exercise and Tumor Blood Flow in Breast Cancer Patients</brief_title>
  <acronym>EXETUMOR2</acronym>
  <official_title>Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research aims at investigating tumor blood flow response to acute exercise in human&#xD;
      cancer patients. It is hypothesized and expected that acute exercise increases tumor blood&#xD;
      flow, which could plausibly increase the efficacy of cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical activity has been applied as an adjunctive therapy in the secondary prevention of&#xD;
      many cancers, but very little is currently known clinically and mechanistically about the&#xD;
      effects of physical activity and exercise on tumor itself. Based on recent evidence from&#xD;
      pre-clinical studies, it is plausible to expect that changes in tumor blood flow and its&#xD;
      heterogeneity, oxygenation, and metabolism due to exercise would increase the delivery of&#xD;
      chemotherapy and other cancer drugs into the tumor increasing the efficacy of cancer&#xD;
      treatment.&#xD;
&#xD;
      Twenty (20) newly diagnosed Breast cancer patients will be recruited to investigate whether&#xD;
      these pre-clinical findings can be extended to humans to serve as an evidence-based&#xD;
      proof-of-concept for the possible inclusion of exercise in the treatment of cancer during&#xD;
      chemotherapy. To study the effect of acute physical exercise on tumor blood flow and its&#xD;
      heterogeneity, supine bicycle exercise in a positron emission tomography (PET) scanner will&#xD;
      be used to exercise Breast cancer patients. These experiments are additional measurements to&#xD;
      their normal treatments, and no new interventional approaches will be conducted in this&#xD;
      study.&#xD;
&#xD;
      The study consists of one fitness test assessment, and tumor blood flow measurements with PET&#xD;
      at rest and during supine cycling exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <intervention_model_description>Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor blood flow</measure>
    <time_frame>Tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. Tumor blood flow at rest and during supine cycling exercise will be measured on the same day.</time_frame>
    <description>Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spatial dispersion (heterogeneity) of tumor blood flow</measure>
    <time_frame>The heterogeneity of tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. The heterogeneity of tumor blood flow at rest and during supine cycling exercise will be measured on the same day.</time_frame>
    <description>Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor blood flow heterogeneity will be determined as voxel variation in perfusion divided by the mean perfusion of the voxels.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cancer, Breast</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experiment consists of a supine bicycle exercise in a positron emission tomography (PET) scanner. Each subject will perform the experiment as well as serve as their own control (tumor blood flow at rest vs. blood flow during exercise).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Positron emission tomography (PET) imaging at rest and during supine bicycle exercise Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal fatigue, anemia, or physical dysfunction due to the disease&#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>Ilkka Heinonen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>staff</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilkka Heinonen, PhD</last_name>
    <phone>+35823138145</phone>
    <email>ilkka.heinonen@utu.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heikki Minn, PhD</last_name>
    <phone>+35823130149</phone>
    <email>heikki.minn@tyks.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Turku PET Centre</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ilkka H Heinonen, PhD</last_name>
      <email>ilkka.heinonen@utu.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT04416087
org study id: T148/2020
nct id: NCT04416087
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This research aims at investigating tumor blood flow response to acute exercise in human
      cancer patients. It is hypothesized and expected that acute exercise increases tumor blood
      flow, which could plausibly increase the efficacy of cancer treatment.
Physical activity has been applied as an adjunctive therapy in the secondary prevention of
      many cancers, but very little is currently known clinically and mechanistically about the
      effects of physical activity and exercise on tumor itself. Based on recent evidence from
      pre-clinical studies, it is plausible to expect that changes in tumor blood flow and its
      heterogeneity, oxygenation, and metabolism due to exercise would increase the delivery of
      chemotherapy and other cancer drugs into the tumor increasing the efficacy of cancer
      treatment.

      Twenty (20) newly diagnosed Breast cancer patients will be recruited to investigate whether
      these pre-clinical findings can be extended to humans to serve as an evidence-based
      proof-of-concept for the possible inclusion of exercise in the treatment of cancer during
      chemotherapy. To study the effect of acute physical exercise on tumor blood flow and its
      heterogeneity, supine bicycle exercise in a positron emission tomography (PET) scanner will
      be used to exercise Breast cancer patients. These experiments are additional measurements to
      their normal treatments, and no new interventional approaches will be conducted in this
      study.

      The study consists of one fitness test assessment, and tumor blood flow measurements with PET
      at rest and during supine cycling exercise.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor blood flow
time frame: Tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. Tumor blood flow at rest and during supine cycling exercise will be measured on the same day.
description: Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.
measure: Spatial dispersion (heterogeneity) of tumor blood flow
time frame: The heterogeneity of tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. The heterogeneity of tumor blood flow at rest and during supine cycling exercise will be measured on the same day.
description: Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor blood flow heterogeneity will be determined as voxel variation in perfusion divided by the mean perfusion of the voxels.
arm group label: Experimental group
arm group type: Experimental
description: The experiment consists of a supine bicycle exercise in a positron emission tomography (PET) scanner. Each subject will perform the experiment as well as serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
intervention type: Other
intervention name: Exercise
description: Positron emission tomography (PET) imaging at rest and during supine bicycle exercise Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ilkka Heinonen, PhD
role: Principal Investigator
affiliation: staff
last name: Ilkka Heinonen, PhD
phone: +35823138145
email: ilkka.heinonen@utu.fi
last name: Heikki Minn, PhD
phone: +35823130149
email: heikki.minn@tyks.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No