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Table 2 Summary of study outcome measures

From: Rationale and design of the Caloric Restriction and Exercise protection from Anthracycline Toxic Effects (CREATE) study: a 3-arm parallel group phase II randomized controlled trial in early breast cancer

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
  1. anth anthracycline chemotherapy treatment, CPET cardiopulmonary exercise test, ESAS Edmonton Symptom Assessment System, LVEF left ventricular ejection fraction
  2. aTypically measured before and after completion of all chemotherapy as standard of care