SarcomaSEBNCT07785882
Sarcoma and Intra-infusion Exercise for Better Outcomes
A study testing Exercise in people with Sarcoma, run by Kira Bloomquist at 1 site in Denmark.
Trial summary
The main goal of this clinical trial is to determine: 1) the safety and 2) feasibility of moderate-intensity, intra-infusion aerobic exercise in people receiving chemotherapy for non-resected sarcoma and 3) assess whether intra-infusion exercise acutely increases tumor perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2027to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initiating at least two series of chemotherapy for non-resected sarcoma at Clinic 6, Herlev Hospital, Denmark
- Eastern Cooperative Oncology Group performance status of 0-2
- No mental or physical disabilities precluding exercise
- Approval by the treating oncologist
- Able to read Danish
- Willing to sign informed consent
Who cannot join
- Home-based chemotherapy
- Infusions lasting under one hour
- Elevated risk for developing cardiac issues (left ventricular ejection fraction ≤50%) based on routine echocardiography
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Oncology, Herlev Hospital
Herlev, Region Sjælland, 2730
About this study
Official title: Sarcoma and Intra-infusion Exercise for Better Outcomes: The SEB-trial
The main goal of this clinical trial is to determine: 1) the safety and 2) feasibility of moderate-intensity, intra-infusion aerobic exercise in people receiving chemotherapy for non-resected sarcoma and 3) assess whether intra-infusion exercise acutely increases tumor perfusion.
The trial aims to answer the following research questions:
Read more
- Is intra-infusion aerobic exercise safe in people receiving chemotherapy for sarcoma?
- Is intra-infusion aerobic exercise feasible in people receiving chemotherapy for sarcoma?
- Does aerobic exercise induce acute increases in tumor perfusion?
- In future work, which patient reported outcomes are relevant to explore in people receiving chemotherapy for sarcoma?
Adverse event data and patient-reported quality-of-life outcomes will be compared to those of a historical control comprising patients who received chemotherapy for sarcoma within three years prior to study initiation.
Participants will:
- Participate in light- to moderate-intensity aerobic exercise during chemotherapy infusion (intra-infusion exercise) for the duration of their treatment protocol.
- Exercise will follow a 15-minute exercise / 15-minute rest interval, totaling 30 minutes of exercise per hour of infusion.
- Prior to initiating chemotherapy, undergo a single 15-minute exercise session. During peak exercise, a radioactive tracer will be injected intravenously followed by a single-photon emission computed tomography and computed tomography (SPECT /CT) scan to obtain images of tumor perfusion. A resting SPECT/CT scan will also be performed.
- Conditions
- Sarcoma
- Being tested
- Exercise
- Keywords
- exercise, chemotherapy, feasibility, adverse events, tumor perfusion
- Medical subject headings
- Sarcoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
See description of study arm
| Study group | Role | What they receive |
|---|---|---|
| Intra-infusion exercise | Experimental | The first cycle of chemotherapy will be delivered as per usual care. During all subsequent cycles, participants will partake in intra-infusion aerobic exercise (e.g. pedal ergometer, stationary bike). Exercise will follow a 15-minute exercise / 15-minute rest interval, totalling 30 minutes of exercise per hour of infusion. Participants will be monitored using the Borg rate of perceived exertion (RPE) scale (range 6-20) and heart rate monitors. Target intensity will be low (Borg RPE 10-12) for the first five minutes, increasing to moderate intensity (Borg RPE 13-15) for the last ten minutes. As a precautionary measure, only low-intensity exercise will be performed when receiving cytostatic agents known to carry an increased risk of cardiotoxicity (e.g. anthracyclines). Exercise will be supervised by a physical therapist with experience in exercise oncology, alongside oncology nurses as per usual care. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events will be extracted from medical records (including adjustment to treatment plans, adjunct medications or procedures) and categorized according to the Common Terminology Criteria for Adverse Events, version 5.0.
In addition, before and after each infusion, the intra-infusion exercise group will be asked whether they have experienced any harmful or undesirable outcomes, with additional prompts to better understand the severity and impact of such events.
Specific adverse events:
Cardiac function and skeletal muscle damage: Routine echocardiography data will be extracted from medical records in both groups. Further, serum troponin I levels (a biomarker used in the early detection of cardiotoxicity) and serum creatine kinase (a biomarker routinely used to assess skeletal muscle damage) will be taken in conjunction with routine blood work in the exercise group.
Measured: From the commencement of chemotherapy and up to six months post-chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.
Feasibility: recruitment rate
Feasibility of intra-infusion exercise will be assessed by analyzing the number accepting participation in intra-infusion exercise vs. number eligible
Measured: From initiation of participant recruitment in the department until recruitment of last participant. Anticipated within one year.
Feasibility: retention rate
Feasibility of intra-infusion exercise will be asessed by analyzing the number of participants who remained in the study vs. number enrolled.
Measured: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Feasibility: attendance rate
Feasibility of intra-infusion exercise be assessed by analyzing the number of intra-infusion exercise sessions completed vs. number possible.
Measured: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Feasibility: Adherence exercise intensity
Feasibility of intra-infusion exercise will be assessed by analyzing the number of exercise sessions meeting exercise intensity target vs. number of exercise sessions possible.
Measured: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention group will be compared to a historical control.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kira Bloomquist
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Center for Physical Activity Research (CFAS), Department of Nuclear Medicine, Herlev Hospital, Department of Oncology, Herlev Hospital, Copenhagen Research Center for Cancer Rehabilitation (CORE-Cancer), Herlev Hospital
- Responsible party
- Sponsor-investigator, Kira Bloomquist, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kira Bloomquist, Physical therapist, MHS, PhD, Principal investigator, Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785882
- Sponsor's protocol ID
- BK26-02661
- Acronym
- SEB
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after de-identification.
Publications
Seet-Lee C, Yee J, Clarke J, Edwards DK. DOES EXERCISE CHANGE BLOOD FLOW TO TUMOURS? ACUTE AEROBIC EXERCISE EFFECTS ON LIVER METASTASES BLOOD FLOW: A CASE SERIES. Journal of Clinical Exercise Physiology. 2024 May;13(s2):364-364. doi:10.31189/2165-7629-13-s2.364
Wiggins JM, Opoku-Acheampong AB, Baumfalk DR, Siemann DW, Behnke BJ. Exercise and the Tumor Microenvironment: Potential Therapeutic Implications. Exerc Sport Sci Rev. 2018 Jan;46(1):56-64. doi: 10.1249/JES.0000000000000137.
PubMed 29166299Seet-Lee C, Yee J, Morahan H, Ross LS, Edwards KM. The effect of aerobic exercise on tumour blood delivery: a systematic review and meta-analysis. Support Care Cancer. 2022 Nov;30(11):8637-8653. doi: 10.1007/s00520-022-07132-0. Epub 2022 Jun 2.
PubMed 35650456Esteves M, Monteiro MP, Duarte JA. The Effects of Physical Exercise on Tumor Vasculature: Systematic Review and Meta-analysis. Int J Sports Med. 2021 Dec;42(14):1237-1249. doi: 10.1055/a-1533-1876. Epub 2021 Aug 2.
PubMed 34341974Miller R, Northey J, Toohey K. Physical Exercise and Cancer: Exploring Chemotherapy Infusion as an Opportunity for Movement. Semin Oncol Nurs. 2020 Oct;36(5):151068. doi: 10.1016/j.soncn.2020.151068. Epub 2020 Sep 29.
PubMed 33008684
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcoma and Intra-infusion Exercise for Better Outcomes: The SEB-trial
- ClinicalTrials.gov ID
- NCT07785882
- Acronym / sponsor ID
- SEB / BK26-02661
- Conditions
- Sarcoma
- Keywords
- exercise, chemotherapy, feasibility, adverse events, tumor perfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Kira BloomquistUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Center for Physical Activity Research (CFAS), Department of Nuclear Medicine, Herlev Hospital, Department of Oncology, Herlev Hospital, Copenhagen Research Center for Cancer Rehabilitation (CORE-Cancer), Herlev Hospital
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
The main goal of this clinical trial is to determine: 1) the safety and 2) feasibility of moderate-intensity, intra-infusion aerobic exercise in people receiving chemotherapy for non-resected sarcoma and 3) assess whether intra-infusion exercise acutely increases tumor perfusion.
The trial aims to answer the following research questions:
- Is intra-infusion aerobic exercise safe in people receiving chemotherapy for sarcoma?
- Is intra-infusion aerobic exercise feasible in people receiving chemotherapy for sarcoma?
- Does aerobic exercise induce acute increases in tumor perfusion?
- In future work, which patient reported outcomes are relevant to explore in people receiving chemotherapy for sarcoma?
Adverse event data and patient-reported quality-of-life outcomes will be compared to those of a historical control comprising patients who received chemotherapy for sarcoma within three years prior to study initiation.
Participants will:
- Participate in light- to moderate-intensity aerobic exercise during chemotherapy infusion (intra-infusion exercise) for the duration of their treatment protocol.
- Exercise will follow a 15-minute exercise / 15-minute rest interval, totaling 30 minutes of exercise per hour of infusion.
- Prior to initiating chemotherapy, undergo a single 15-minute exercise session. During peak exercise, a radioactive tracer will be injected intravenously followed by a single-photon emission computed tomography and computed tomography (SPECT /CT) scan to obtain images of tumor perfusion. A resting SPECT/CT scan will also be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention group will be compared to a historical control.
| Arm | Type | Receives |
|---|---|---|
| Intra-infusion exercise | Experimental | Other: ExerciseThe first cycle of chemotherapy will be delivered as per usual care. During all subsequent cycles, participants will partake in intra-infusion aerobic exercise (e.g. pedal ergometer, stationary bike). Exercise will follow a 15-minute exercise / 15-minute rest interval, totalling 30 minutes of exercise per hour of infusion. Participants will be monitored using the Borg rate of perceived exertion (RPE) scale (range 6-20) and heart rate monitors. Target intensity will be low (Borg RPE 10-12) for the first five minutes, increasing to moderate intensity (Borg RPE 13-15) for the last ten minutes. As a precautionary measure, only low-intensity exercise will be performed when receiving cytostatic agents known to carry an increased risk of cardiotoxicity (e.g. anthracyclines). Exercise will be supervised by a physical therapist with experience in exercise oncology, alongside oncology nurses as per usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Initiating at least two series of chemotherapy for non-resected sarcoma at Clinic 6, Herlev Hospital, Denmark
- Eastern Cooperative Oncology Group performance status of 0-2
- No mental or physical disabilities precluding exercise
- Approval by the treating oncologist
- Able to read Danish
Key exclusion criteria (3 listed)
- Home-based chemotherapy
- Infusions lasting under one hour
- Elevated risk for developing cardiac issues (left ventricular ejection fraction ≤50%) based on routine echocardiography
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 |
|---|---|---|
| ExerciseSee description of study arm | Other | Intra-infusion exercise |
Primary outcome
Adverse events
Time frame: From the commencement of chemotherapy and up to six months post-chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.
Adverse events will be extracted from medical records (including adjustment to treatment plans, adjunct medications or procedures) and categorized according to the Common Terminology Criteria for Adverse Events, version 5.0. In addition, before and after each infusion, the intra-infusion exercise group will be asked whether they have experienced any harmful or undesirable outcomes, with additional prompts to better understand the severity and impact of such events. Specific adverse events: Cardiac function and skeletal muscle damage: Routine echocardiography data will be extracted from medical records in both groups. Further, serum troponin I levels (a biomarker used in the early detection of cardiotoxicity) and serum creatine kinase (a biomarker routinely used to assess skeletal muscle damage) will be taken in conjunction with routine blood work in the exercise group.
Feasibility: recruitment rate
Time frame: From initiation of participant recruitment in the department until recruitment of last participant. Anticipated within one year.
Feasibility of intra-infusion exercise will be assessed by analyzing the number accepting participation in intra-infusion exercise vs. number eligible
Feasibility: retention rate
Time frame: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Feasibility of intra-infusion exercise will be asessed by analyzing the number of participants who remained in the study vs. number enrolled.
Feasibility: attendance rate
Time frame: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Feasibility of intra-infusion exercise be assessed by analyzing the number of intra-infusion exercise sessions completed vs. number possible.
Feasibility: Adherence exercise intensity
Time frame: From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).
Feasibility of intra-infusion exercise will be assessed by analyzing the number of exercise sessions meeting exercise intensity target vs. number of exercise sessions possible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- BackgroundSeet-Lee C, Yee J, Clarke J, Edwards DK. DOES EXERCISE CHANGE BLOOD FLOW TO TUMOURS? ACUTE AEROBIC EXERCISE EFFECTS ON LIVER METASTASES BLOOD FLOW: A CASE SERIES. Journal of Clinical Exercise Physiology. 2024 May;13(s2):364-364. doi:10.31189/2165-7629-13-s2.364
- Background: PubMed 29166299Wiggins JM, Opoku-Acheampong AB, Baumfalk DR, Siemann DW, Behnke BJ. Exercise and the Tumor Microenvironment: Potential Therapeutic Implications. Exerc Sport Sci Rev. 2018 Jan;46(1):56-64. doi: 10.1249/JES.0000000000000137.
- Background: PubMed 35650456Seet-Lee C, Yee J, Morahan H, Ross LS, Edwards KM. The effect of aerobic exercise on tumour blood delivery: a systematic review and meta-analysis. Support Care Cancer. 2022 Nov;30(11):8637-8653. doi: 10.1007/s00520-022-07132-0. Epub 2022 Jun 2.
- Background: PubMed 34341974Esteves M, Monteiro MP, Duarte JA. The Effects of Physical Exercise on Tumor Vasculature: Systematic Review and Meta-analysis. Int J Sports Med. 2021 Dec;42(14):1237-1249. doi: 10.1055/a-1533-1876. Epub 2021 Aug 2.
- Background: PubMed 33008684Miller R, Northey J, Toohey K. Physical Exercise and Cancer: Exploring Chemotherapy Infusion as an Opportunity for Movement. Semin Oncol Nurs. 2020 Oct;36(5):151068. doi: 10.1016/j.soncn.2020.151068. Epub 2020 Sep 29.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after de-identification.
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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.
Kira Bloomquist, Physical therapist, MHS, PhD principal investigator
Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet
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 Sarcoma, run by Kira Bloomquist at 1 site in Denmark.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kira Bloomquist, Physical therapist, MHS, PhD (+45 35457362, kira.bloomquist@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From the commencement of chemotherapy and up to six months post-chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07785882, which also lists 5 linked publications.
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 25 Aug 2026.