Cancer cachexia
Conditions
Brief summary
Change from baseline body weight at Week 12.
Detailed description
Change from baseline in each of the physical activity and gait endpoints measured with remote digital sensors at Week 12: Moderate to vigorous physical activity time; Sedentary activity time; Non sedentary activity time; Total vector magnitude; Mean activity level during M6min; Mean gait speed; 95th percentile gait speed., Change from baseline in FAACT sub-scale scores at Week 12: FAACT-ACS; FAACT-5IASS., Change from baseline score for the questions from the CRCSD at Week 12 related to: Anorexia/appetite; Nausea and vomiting; Fatigue., Incidence of adverse events, safety laboratory tests, vital signs and ECG abnormalities
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline body weight at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in each of the physical activity and gait endpoints measured with remote digital sensors at Week 12: Moderate to vigorous physical activity time; Sedentary activity time; Non sedentary activity time; Total vector magnitude; Mean activity level during M6min; Mean gait speed; 95th percentile gait speed., Change from baseline in FAACT sub-scale scores at Week 12: FAACT-ACS; FAACT-5IASS., Change from baseline score for the questions from the CRCSD at Week 12 related to: Anorexia/appetite; Nausea and vomiting; Fatigue., Incidence of adverse events, safety laboratory tests, vital signs and ECG abnormalities | — |
Countries
Bulgaria, Poland, Slovakia, Spain