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Table 4 Summary of study outcome measures and timing of assessment

From: Rationale and design of the Diet Restriction and Exercise-induced Adaptations in Metastatic breast cancer (DREAM) study: a 2-arm, parallel-group, phase II, randomized control trial of a short-term, calorie-restricted, and ketogenic diet plus exercise during intravenous chemotherapy versus usual care

 

Assessment Method

Pre cycle 1

Post cycle 3

Post cycle 6

2-year follow-up

Primary Outcome

 Target lesion size change after 6 cycles (mm)

CT Scan

X

 

X

 

Secondary Outcomes

 Target lesion apparent diffusion coefficient (mm2/s)

MRI

X

 

X

 

 Target lesion size change after 3 cycles (mm)

CT Scan

X

X

  

Tertiary Outcomes

 Left ventricular ejection fraction (%)

MRI

X

 

X

 

 Left ventricular global longitudinal strain (%)

MRI

X

 

X

 

 Left ventricular mass (g/m2)

MRI

X

 

X

 

 Liver fat fraction (%)

MRI

X

 

X

 

 Liver T1 time (ms)

MRI

X

 

X

 

 Thigh skeletal muscle T1 time (ms)

MRI

X

 

X

 

 Thigh skeletal muscle volume (mL)

MRI

X

 

X

 

 Thigh skeletal muscle fat fraction (%)

MRI

X

 

X

 

 Treatment symptomsa

Rotterdam Symptom Checklist

X

X

X

 

 Quality of life

FACT-Fatigue Questionnaire

X

X

X

 

 Fatigue

FACT-Fatigue Questionnaire

X

X

X

 

Exploratory Outcomes

 Progression-free survival (months)

Medical records

   

X

 Overall survival (months)

Medical records

   

X

  1. a Treatment symptoms are assessed after every cycle