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Exercise and Tumor Blood Flow (EXETUMOR)

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ClinicalTrials.gov Identifier: NCT03987724
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ilkka Heinonen, University of Turku

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tumor Blood Flow at Rest and During Exercise Other: Positron emission tomography (PET) imaging at rest and during supine bicycle exercise Not Applicable

Detailed Description:

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.

Eight (8) newly diagnosed Hodgkin lymphoma 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 Hodgkin lymphoma 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Acute Exercise on Tumor Blood Flow
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
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).
Other: 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.




Primary Outcome Measures :
  1. 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. ]
    Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.


Secondary Outcome Measures :
  1. 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. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed Hodgkin lymphoma

Exclusion Criteria:

  • abnormal fatigue, anemia, or physical dysfunction due to the disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987724


Contacts
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Contact: Ilkka Heinonen, PhD +35823138145 ilkka.heinonen@utu.fi
Contact: Heikki Minn, MD, PhD +35823130149 heikki.minn@tyks.fi

Locations
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Finland
Turku PET Centre Recruiting
Turku, Finland, 20521
Contact: Ilkka H Heinonen, PhD    +35823138145    ilkka.heinonen@utu.fi   
Principal Investigator: Ilkka Heinonen, PhD         
Sub-Investigator: Heikki Minn, MD, PhD         
Sub-Investigator: Sirkku Jyrkkiö, MD, PhD         
Sub-Investigator: Ilja Nystrand, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Ilkka Heinonen, PhD University of Turku

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Responsible Party: Ilkka Heinonen, Adjunct professor, University of Turku
ClinicalTrials.gov Identifier: NCT03987724     History of Changes
Other Study ID Numbers: T187/2019
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilkka Heinonen, University of Turku:
Clinical trial
Positron emission tomography
Exercise