Study visit schedule
Assessment | Baseline | Period 1 | Washout/ second visit | Period 2 | Final visit | ||||||
D0 | D1 | D14 (±1) | D26 | D28 | D29–31 (±3) | D32 (±3) | D46 (±1) | D58 | D60 | D61 (±3) | |
Blood collection (biomarker analysis, safety blood tests) | X | First dose of study drug/placebo for period 1 | X | Final dose of study drug/placebo for period 1 | X | First dose of study drug/placebo for period 2 | X | Final dose of study drug/placebo for period 2 | X | ||
DXA | X | X | X | ||||||||
Weight | X | X | X | ||||||||
ECG | X | X | X | ||||||||
QoL: FACT-L and ACS | X | X | X | ||||||||
Accelerometer | X* | X* | X* | ||||||||
24 hours dietary recall | X | X | X | ||||||||
Assessment of toxicity | X | X | X | X | X |
*Wear accelerometer.
ACS, Anorexia Cachexia Scale; DXA, dual X-ray absorptiometry; FACT-L, Functional Assessment of Cancer Therapy—Lung; QoL, quality of life.