Sarcoma and Intra-infusion Exercise for Better Outcomes

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:

• 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.

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