Sarcoma and Intra-infusion Exercise for Better Outcomes

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.

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

Feasibility of intra-infusion exercise will be asessed by analyzing the number of participants who remained in the study vs. number enrolled.

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

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.

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.

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.

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.

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