ClinicalTrials.gg
Not yet recruitingNCT07785882SEBUpdated Aug 25, 2026

Sarcoma and Intra-infusion Exercise for Better Outcomes

An interventional study of Exercise in Sarcoma, sponsored by Kira Bloomquist. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Kira Bloomquist · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 39 studies in Sarcoma with a site in Denmark — 12 open to participants now, 13 under way, none of them phase 3. Sarcoma · Denmark.

Planned enrollment
35th of 37
16 · median 128
Started
2027
the only one that year
No phase
4 of 39
2 open now
Primary completion
2028-10
later than 8 of 12 live
Registered
38th of 39
by date

Among the 39 studies in Sarcoma with a site in Denmark, this one is the 35th largest by planned enrollment of the 37 interventional ones, is the only one that started in 2027, is one of 4 with no phase, reaches primary completion later than 8 of the 12 other live ones, and was the 38th registered.

By phase

39 studies; the count open now beside each. This study's row is marked.

Phase 311 · 0 open
Phase 29 · 4 open
Phase 16 · 2 open
Phase 1/26 · 2 open
No phasethis study4 · 2 open
Observational2 · 2 open
Phase 2/31 · 0 open

By the year they started

First in 1993; this study’s year is marked. 1 started in 2027.

Size and results

Median enrollment 128 across the 37 interventional studies, 100 across the 2 observational. Of the 22 that completed or were terminated, 11 (50%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 39 studies in Sarcoma with a site in Denmark, or all of them as a file.
02

Study 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.

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.
03

Conditions studied

  • Sarcoma

Keywords

  • exercise
  • chemotherapy
  • feasibility
  • adverse events
  • tumor perfusion
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Initiating at least two series of chemotherapy for non-resected sarcoma at Clinic 6, Herlev Hospital, Denmark
  • performance status of 0-2
  • No mental or physical disabilities precluding exercise
  • Approval by the treating oncologist
  • Able to read Danish
  • Willing to sign

Exclusion criteria

Exclusion Criteria:

  • Home-based chemotherapy
  • Infusions lasting under one hour
  • Elevated risk for developing cardiac issues ( ≤50%) based on routine echocardiography
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Intra-infusion exercise

    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.

    Other: Exercise

Interventions

  • OtherExercise

    See description of study arm

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. Feasibility: recruitment rate

    Feasibility of intra-infusion exercise will be assessed by analyzing the number accepting participation in intra-infusion exercise vs. number eligible

    Time frame: From initiation of participant recruitment in the department until recruitment of last participant. Anticipated within one year.

  3. 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.

    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).

  4. Feasibility: attendance rate

    Feasibility of intra-infusion exercise be assessed by analyzing the number of intra-infusion exercise sessions completed vs. number possible.

    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).

  5. 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.

    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).

Other outcomes

  1. Tumor perfusion

    In the intra-infusion exercise group, tumor perfusion under resting and exercise conditions will be assessed prior to initiating chemotherapy using single-photon emission computed tomography and computed tomography (SPECT/CT) with radioactive tracer (99mTc-Sestamibi (MIBI)). During exercise conditions, participants will be injected intravenously with MIBI at the end of a 15-minute exercise session (moderate target intensity). Because MIBI does not wash out or redistribute significantly, the images captured using SPECT/CT within 30-60 minutes reflect the perfusion at the exact moment of injection, providing a snapshot of blood flow in the tumor.

    Time frame: Within a one-week time frame, prior to chemotherapy initiation.

  2. Patient-reported quality-of-life

    This is an exploratory outcome to assess which patient reported outcomes are relevant to explore in future work. Quality-of-life parameters using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) have been collected as part of routine care (in conjunction with scan result oncology consults) since 2021. As such quality-of-life data is available for both groups through medical records. This well-validated, questionnaire comprises five functional scales, nine symptom scales or items and a global health status/quality of life scale. Values range from 0 to 100. Whether a higher score means a better or worse outcome depends on the specific scale type: higher scores indicate a better outcome for functional and global health scales, but a worse outcome for symptom scales.

    Time frame: From enrollment and up to six months after chemotherapy

  3. Patient-reported emotional well-being

    This is an exploratory outcome to assess which patient-reported outcomes are relevant to explore in future work. In addition to patient-reported quality-of life (collected as usual care in conjunction with scan result oncology consults since 2021) the intra-infusion exercise group will also be asked to fill out the Hospital Anxiety and Depression Scale (HADS). This 14-item questionnaire is widely used in cancer and screens for anxiety and depressive states with values ranging from 0 to 21 for each individual subscale (anxiety and depression), or 42 for the combined total score. Higher scores mean a worse outcome, indicating higher levels of anxiety, depression, or overall psychological distress.

    Time frame: From enrollment and up to six months post-treatment.

  4. Experience and acceptability of intra-infusion exercise

    A semi-structured interview will be carried out to explore patient-centered experience and acceptability of intra-infusion exercise.

    Time frame: After completion of chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.

07

Study locations

1 site
08

References and documents

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 29166299 ↗
  • Seet-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 35650456 ↗
  • Esteves 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 34341974 ↗
  • Miller 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 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in publications, after de-identification.

Supporting information: Study protocol, Statistical analysis plan

Time frame: After publication and up to five years.

Access criteria: Requests should be directed to the Principal Investigator's email, and will be available to researchers who provide a methodologically sound proposal (e.g. systematic review and meta-analysis).

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Oct 2028, 21 months later.

Of 144 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 21 months is below that.

Counting every sponsor, half of 147 studies reached it within 59 months; a quarter within 34 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 25, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Oct 31, 2028
CompletionEst.
Oct 31, 2028
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07785882
Lead sponsor
Kira Bloomquist
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
Kira Bloomquist (Researcher, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Aug 25, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Oct 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Aug 25, 2026

Study contacts

Kira Bloomquist, Physical therapist, MHS, PhD
Contact
kira.bloomquist@regionh.dk
+45 35457362
Anders Vinther, Physical therapist, PhD
Contact
Anders.Vinther@regionh.dk
+45 26808710
Kira Bloomquist, Physical therapist, MHS, PhD
principal investigator · Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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