- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987724
Exercise and Tumor Blood Flow (EXETUMOR)
The Effects of Acute Exercise on Tumor Blood Flow
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ilkka Heinonen, PhD
- Phone Number: +35823138145
- Email: ilkka.heinonen@utu.fi
Study Contact Backup
- Name: Heikki Minn, MD, PhD
- Phone Number: +35823130149
- Email: heikki.minn@tyks.fi
Study Locations
-
-
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Turku, Finland, 20521
- Recruiting
- Turku PET Centre
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Sub-Investigator:
- Heikki Minn, MD, PhD
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Sub-Investigator:
- Sirkku Jyrkkiö, MD, PhD
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Sub-Investigator:
- Ilja Nystrand, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- newly diagnosed Hodgkin lymphoma
Exclusion Criteria:
- abnormal fatigue, anemia, or physical dysfunction due to the disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
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Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilkka Heinonen, PhD, University of Turku
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- T187/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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