EXETUMOR2: Exercise and Tumor Blood Flow in Breast Cancer Patients

Sponsor

Turku University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04416087

Collaborator

(none)

Enrollment

Location

Arm

51.8

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast	Other: Exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

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).Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)

Actual Study Start Date :

Sep 7, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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).	Other: Exercise 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.

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).

Other: Exercise

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.

Outcome Measures

Primary Outcome Measures

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.]
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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

newly diagnosed breast cancer

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turku PET Centre	Turku		Finland	20521

Sponsors and Collaborators

Turku University Hospital

Investigators

Principal Investigator: Ilkka Heinonen, PhD, staff

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Turku University Hospital

ClinicalTrials.gov Identifier:

NCT04416087

Other Study ID Numbers:

T148/2020

First Posted:

Jun 4, 2020

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Oct 6, 2020