Cancer Anorexia
Conditions
Brief summary
Change in lean body mass as determined by weight and DEXA scans at 4, 8, and 12 weeks., Change in anorexia as determined by a visual analog scale (VAS) and (FAACT) questionnaire., Change in KPS.
Detailed description
Safety: Assessment of the safety profile of ART27.13 by analyzing the type of, frequency, and severity of adverse drug effects as determined by reporting AEs and evaluation of routine chemistry and hematologic values, urinalyses, vital signs, and electrocardiograms., Quality of Life: Assess QoL using the Functional Assessment of Anorexia Cachexia Therapy (FAACT), the patientgenerated subjective global assessment (PG-SGA), the EORTC QLQ-C15-PAL, and revised Edmonton Symptom Assessment Scale (ESAS-r) questionnaires
Interventions
DRUGART27.13
DRUGPlacebo
Sponsors
Artelo Biosciences Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lean body mass as determined by weight and DEXA scans at 4, 8, and 12 weeks., Change in anorexia as determined by a visual analog scale (VAS) and (FAACT) questionnaire., Change in KPS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Assessment of the safety profile of ART27.13 by analyzing the type of, frequency, and severity of adverse drug effects as determined by reporting AEs and evaluation of routine chemistry and hematologic values, urinalyses, vital signs, and electrocardiograms., Quality of Life: Assess QoL using the Functional Assessment of Anorexia Cachexia Therapy (FAACT), the patientgenerated subjective global assessment (PG-SGA), the EORTC QLQ-C15-PAL, and revised Edmonton Symptom Assessment Scale (ESAS-r) questionnaires | — |
Countries
Ireland, Norway
Outcome results
None listed