Clinical trial NCT04416087: Exercise and Tumor Blood Flow in Breast Cancer Patients
Official title: Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Breast
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed breast cancer

Exclusion Criteria:

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

Primary outcomes:
measure: Tumor blood flow
timeFrame: 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:
measure: Spatial dispersion (heterogeneity) of tumor blood flow
timeFrame: 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.
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
Study officials:
affiliation: staff
name: Ilkka Heinonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: