Exercise and Tumor Blood Flow in Breast Cancer Patients
EXETUMOR2
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 6, 2020
October 1, 2020
4.3 years
June 1, 2020
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor blood flow
Measured with PET and radiowater (\[(15)O\]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.
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 Outcomes (1)
Spatial dispersion (heterogeneity) of tumor blood flow
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.
Study Arms (1)
Experimental group
EXPERIMENTALThe 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- newly diagnosed breast cancer
You may not qualify if:
- abnormal fatigue, anemia, or physical dysfunction due to the disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku PET Centre
Turku, 20521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilkka Heinonen, PhD
staff
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 4, 2020
Study Start
September 7, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share