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

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		x^a
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

ISSN: 1471-2407