TumorEXETUMOR3NCT04990856
Exercise and Tumor Blood Flow in Lymphoma And Breast Cancer Patients (EXETUMOR 3)
A study testing Exercise in people with Tumor, run by Turku University Hospital at 1 site in Finland.
Trial summary
Recent pre-clinical studies strongly suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values. However, to the best of our knowledge these blood flow aspects have never been addressed clinically. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFinland
- Study dates
- 10 Aug 2021to 31 Dec 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a disease of newly diagnosed breast cancer, Hodgkin lymphoma, recurrent Hodgkin lymphoma and non-Hodgkin lymphoma with neck and thorax involvement.
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, ilkka.heinonen@utu.fi
About this study
Official title: Tumor Blood Flow After Physical Exercise in Breast Cancer and Lymphoma Patients (Exetumor3 Study)
Recent pre-clinical studies strongly suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values. However, to the best of our knowledge these blood flow aspects have never been addressed clinically. Therefore, this research aims at investigating tumor blood flow response to exercise in human cancer patients. To address this goal, in total twenty (20) newly diagnosed breast cancer and eight (8) lymphoma patients will be recruited for the present acute exercise and tumor perfusion clinical trial. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, 30 minute bicycle exercise will be used to exercise these patients. Tumor blood flow will be measured by positron emission tomography at rest before and after the exercise. If the hypothesis of increased blood flow in response to exercise will be detected, this project has the potential to increase the basic physiological and mechanistic understanding of tumor microvasculature function in humans, which is also clinically highly relevant and can have long-lasting influences in the field in the future. Thus, the results from the project can be a breakthrough for cancer treatment, its mechanistic arguments, and thus renewal of evidence-based medicine and patient care.
Read the detailed description
In regards to cancer, it would be reasonable to assume that also cancer behaves like all other inactive tissues in a body during exercise, meaning that also blood flow in the tumor environment is reduced particularly when exercise intensity increases. However, recent pre-clinical studies suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values (6; 18; 19) as increased cardiac output and blood pressure enhance perfusion pressure in the tumor. This improves its oxygenation (6; 18; 19), which is important as tumor hypoxia negatively affects the efficacy of treatment (27). Tumor hypoxia is promoted by heterogeneous blood flow in the tumor, but according to these pre-clinical studies exercise reduces the heterogeneity of tumor perfusion. However, it is not currently known if this is the case in patients, and it might be that tumor perfusion is actually decreased during exercise, but increased post-exercise, but this has never been addressed in clinical patients and is therefore the aim of the present study. Importantly, advanced imaging methods are available 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.
OBJECTIVES AND PURPOSE
The most important objective of this directly translatable and highly inter- disciplinary imaging, physical activity, health and medical research in the acute exercise study setting is:
To investigate whether acute moderate intensity exercise increases tumor blood flow
-It is hypothesized and expected that exercise increases tumor blood flow, documented as perfusion increase after acute exercise
STUDY DESIGN Each subject will serve their own control (tumor blood flow at rest vs. blood flow after exercise). Tumor blood flow will be measured with positron emission tomography (PET). To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, bicycle exercise before PET scan will be used to exercise breast cancer and lymphoma cancer patients. These experiments are additional measurements to their normal treatments, and no new interventional approaches will be conducted in this study.
- Conditions
- Tumor
- Being tested
- Exercise
- Keywords
- tumor, PET, exercise, blood flow
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Tumor blood flow after acute exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Blood flow of the tumor experimented Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Blood flow measured by PET imaging
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start10 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkka Heinonen, Turku University Hospital
- Investigators
- Ilkka Heinonen, Principal investigator, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990856
- Sponsor's protocol ID
- T06/024/21
- Acronym
- EXETUMOR3
- Status last verified
- Jul 2021
- First submitted
- 3 Jun 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Blood Flow After Physical Exercise in Breast Cancer and Lymphoma Patients (Exetumor3 Study)
- ClinicalTrials.gov ID
- NCT04990856
- Acronym / sponsor ID
- EXETUMOR3 / T06/024/21
- Conditions
- Tumor
- Keywords
- tumor, PET, exercise, blood flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 10 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Aug 2021 (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.
Recent pre-clinical studies strongly suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values. However, to the best of our knowledge these blood flow aspects have never been addressed clinically. Therefore, this research aims at investigating tumor blood flow response to exercise in human cancer patients. To address this goal, in total twenty (20) newly diagnosed breast cancer and eight (8) lymphoma patients will be recruited for the present acute exercise and tumor perfusion clinical trial. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, 30 minute bicycle exercise will be used to exercise these patients. Tumor blood flow will be measured by positron emission tomography at rest before and after the exercise. If the hypothesis of increased blood flow in response to exercise will be detected, this project has the potential to increase the basic physiological and mechanistic understanding of tumor microvasculature function in humans, which is also clinically highly relevant and can have long-lasting influences in the field in the future. Thus, the results from the project can be a breakthrough for cancer treatment, its mechanistic arguments, and thus renewal of evidence-based medicine and patient care.
Detailed description
In regards to cancer, it would be reasonable to assume that also cancer behaves like all other inactive tissues in a body during exercise, meaning that also blood flow in the tumor environment is reduced particularly when exercise intensity increases. However, recent pre-clinical studies suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values (6; 18; 19) as increased cardiac output and blood pressure enhance perfusion pressure in the tumor. This improves its oxygenation (6; 18; 19), which is important as tumor hypoxia negatively affects the efficacy of treatment (27). Tumor hypoxia is promoted by heterogeneous blood flow in the tumor, but according to these pre-clinical studies exercise reduces the heterogeneity of tumor perfusion. However, it is not currently known if this is the case in patients, and it might be that tumor perfusion is actually decreased during exercise, but increased post-exercise, but this has never been addressed in clinical patients and is therefore the aim of the present study. Importantly, advanced imaging methods are available 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.
OBJECTIVES AND PURPOSE
The most important objective of this directly translatable and highly inter- disciplinary imaging, physical activity, health and medical research in the acute exercise study setting is:
To investigate whether acute moderate intensity exercise increases tumor blood flow
-It is hypothesized and expected that exercise increases tumor blood flow, documented as perfusion increase after acute exercise
STUDY DESIGN Each subject will serve their own control (tumor blood flow at rest vs. blood flow after exercise). Tumor blood flow will be measured with positron emission tomography (PET). To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, bicycle exercise before PET scan will be used to exercise breast cancer and lymphoma cancer patients. These experiments are additional measurements to their normal treatments, and no new interventional approaches will be conducted in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: ExerciseBlood flow of the tumor experimented |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a disease of newly diagnosed breast cancer, Hodgkin lymphoma, recurrent Hodgkin lymphoma and non-Hodgkin lymphoma with neck and thorax involvement.
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 |
|---|---|---|
| ExerciseTumor blood flow after acute exercise | Procedure or surgery | Experimental arm |
Primary outcome
Blood flow
Time frame: up to 12 months
Blood flow measured by PET imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Yes
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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 principal investigator
Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Tumor, 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 5 Aug 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 (+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?
Blood flow (time frame: up to 12 months). 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 5 Aug 2021.