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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
16
See description of study arm
Department of Oncology, Herlev Hospital
Herlev, Region Sjælland, Denmark
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.
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.
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).
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).
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).
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