Clinical trial · Interventional
Sarcoma and Intra-infusion Exercise for Better Outcomes
Sarcoma and Intra-infusion Exercise for Better Outcomes: The SEB-trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-infusion exercise
- description
- 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.
- interventionNames
- Other: Exercise
Primary outcomes (5)
- measure
- Adverse events
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Home-based chemotherapy * Infusions lasting under one hour * Elevated risk for developing cardiac issues (left ventricular ejection fraction ≤50%) based on routine echocardiography
References
Publications (5)
- 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
- BACKGROUNDWiggins 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. PMID 29166299
- BACKGROUNDSeet-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. PMID 35650456
- BACKGROUNDEsteves 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. PMID 34341974
- BACKGROUNDMiller 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. PMID 33008684