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NCT07785882
Sarcoma and Intra-infusion Exercise for Better Outcomes
Conditions: Sarcoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Kira Bloomquist
Location: Department of Oncology, Herlev Hospital Herlev Region Sjælland
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07785882). StuddyBuddy aggregates publicly available trial information.