Exercise and Tumor Blood Flow in Breast Cancer Patients (EXETUMOR2)
Primary Purpose
Cancer, Breast
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cancer, Breast
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed breast cancer
Exclusion Criteria:
- abnormal fatigue, anemia, or physical dysfunction due to the disease
Sites / Locations
- Turku PET CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm 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).
Outcomes
Primary Outcome Measures
Tumor blood flow
Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.
Secondary Outcome Measures
Spatial dispersion (heterogeneity) of tumor blood flow
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.
Full Information
NCT ID
NCT04416087
First Posted
June 1, 2020
Last Updated
October 5, 2020
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04416087
Brief Title
Exercise and Tumor Blood Flow in Breast Cancer Patients
Acronym
EXETUMOR2
Official Title
Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm 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(s)
Exercise
Intervention 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.
Primary Outcome Measure Information:
Title
Tumor blood flow
Description
Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean 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.
Secondary Outcome Measure Information:
Title
Spatial dispersion (heterogeneity) of tumor blood flow
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed breast cancer
Exclusion Criteria:
abnormal fatigue, anemia, or physical dysfunction due to the disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilkka Heinonen, PhD
Phone
+35823138145
Email
ilkka.heinonen@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Heikki Minn, PhD
Phone
+35823130149
Email
heikki.minn@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilkka Heinonen, PhD
Organizational Affiliation
staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku PET Centre
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilkka H Heinonen, PhD
Email
ilkka.heinonen@utu.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise and Tumor Blood Flow in Breast Cancer Patients
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