Tumor Blood Flow at Rest and During ExerciseEXETUMORNCT03987724
Exercise and Tumor Blood Flow
A study testing Positron emission tomography (PET) imaging at rest and during supine bicycle exercise in people with Tumor Blood Flow at Rest and During Exercise, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tumor Blood Flow at Rest and During Exercise
- What is being tested?
- Positron emission tomography (PET) imaging at rest and during supine bicycle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFinland
- Study dates
- 17 Sep 2020to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- newly diagnosed Hodgkin lymphoma
Who cannot join
- abnormal fatigue, anemia, or physical dysfunction due to the disease
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku PET Centre
Turku, 20521
Ilkka H Heinonen, PhD, +35823138145, ilkka.heinonen@utu.fi
Ilkka Heinonen, PhD
About this study
Official title: The Effects of Acute Exercise on Tumor Blood Flow
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.
Read the 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.
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.
- Being tested
- Positron emission tomography (PET) imaging at rest and during supine bicycle exercise
- Keywords
- Clinical trial, Positron emission tomography, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography (PET) imaging at rest and during supine bicycle exerciseOther
Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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). Receives: Other: Positron emission tomography (PET) imaging at rest and during supine bicycle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor blood flow
Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start17 Sep 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Blood Flow at Rest and During ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkka Heinonen, University of Turku
- Investigators
- Ilkka Heinonen, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987724
- Sponsor's protocol ID
- T187/2019
- Acronym
- EXETUMOR
- Status last verified
- Feb 2021
- First submitted
- 13 Jun 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Exercise on Tumor Blood Flow
- ClinicalTrials.gov ID
- NCT03987724
- Acronym / sponsor ID
- EXETUMOR / T187/2019
- Keywords
- Clinical trial, Positron emission tomography, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject will serve as their own control (tumor blood flow at rest vs. blood flow during exercise).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Positron emission tomography (PET) imaging at rest and during supine bicycle exerciseThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed Hodgkin lymphoma
Key exclusion criteria (1 listed)
- abnormal fatigue, anemia, or physical dysfunction due to the disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography (PET) imaging at rest and during supine bicycle exerciseTumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise. | Other | Experimental group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Heinonen, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron emission tomography (PET) imaging at rest and during supine bicycle exercise in people with Tumor Blood Flow at Rest and During Exercise, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilkka Heinonen, PhD (+35823138145, ilkka.heinonen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.