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
|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|
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 :||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)|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987724
|Contact: Ilkka Heinonen, PhDemail@example.com|
|Contact: Heikki Minn, MD, PhDfirstname.lastname@example.org|
|Turku PET Centre||Recruiting|
|Turku, Finland, 20521|
|Contact: Ilkka H Heinonen, PhD +35823138145 email@example.com|
|Principal Investigator: Ilkka Heinonen, PhD|
|Sub-Investigator: Heikki Minn, MD, PhD|
|Sub-Investigator: Sirkku Jyrkkiö, MD, PhD|
|Sub-Investigator: Ilja Nystrand, MD|
|Principal Investigator:||Ilkka Heinonen, PhD||University of Turku|