Table 2.
Summary of study outcome measures
| Measure | Assessment Method | 72+ h pre-anth | 24 h post 1st & last anth | 2–3 w post last anth | 1 y post 1st anth | 5 y post 1st anth |
|---|---|---|---|---|---|---|
| Primary Outcome: | ||||||
| LVEF reserve (peak – rest) | MRI | x | x | x | ||
| Secondary Cardiac Outcomes: | ||||||
| Peak and resting LVEF | MRI | x | x | x | ||
| Resting and peak LV strain | MRI | x | x | x | ||
| LV volumes and cardiac output | MRI | x | x | x | ||
| Myocardial T1 | MRI | x | x | x | ||
| LV mass | MRI | x | x | x | ||
| NT-proBNP | Venipuncture | x | x | x | ||
| Secondary Vascular Outcome: | ||||||
| Ascending and descending aortic distensibility | MRI | x | x | x | ||
| Secondary Skeletal Muscle Outcomes: | ||||||
| Lower leg oxygen extraction | MRI | x | x | x | ||
| Lower leg oxygen consumption | MRI | x | x | x | ||
| Thigh muscle mass | MRI | x | x | x | ||
| Thigh muscle quality | MRI | x | x | x | ||
| Secondary Integrative Outcomes: | ||||||
| Whole body oxygen consumption reserve | CPET | x | x | x | ||
| Treatment symptoms | Rotterdam Symptom Checklist | x | x | x | ||
| Exploratory Outcomes: | ||||||
| Tumor size | Ultrasound | x | xa | |||
| Quality of life | FACT-General questionnaire | x | x | x | ||
| Fatigue | FACT-Fatigue questionnaire | x | x | x | ||
| Markers of oxidative stress/antioxidants | Venipuncture | x | x | |||
| Clinical Outcomes | x | x | ||||
| Safety Outcomes: | ||||||
| Clinically reported symptoms | ESAS | Will be extracted from clinical records for intervention period | ||||
| Intervention-related symptoms or adverse events | Food diary, Exercise session log | Will be collected for each intervention delivered | ||||
anth anthracycline chemotherapy treatment, CPET cardiopulmonary exercise test, ESAS Edmonton Symptom Assessment System, LVEF left ventricular ejection fraction
aTypically measured before and after completion of all chemotherapy as standard of care