Palliadelic Treatment to Reduce Psychological Distress and Improved Quality of Life in Pancreatobiliary Cancer Patients with a Parallel Assessment of Healthcare Utilization and Family Wellbeing
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Lukas, Lou
Eligibility: https://clinicaltrials.gov/study/NCT05220046?term=NCT05220046&rank=1
Summary
Primary objective: To establish the feasibility of conducting a clinical trial using a psilocybin-based intervention to treat psychological distress in participants with inoperable pancreas or biliary tract cancer in the outpatient palliative care setting.
Secondary objectives:
To measure short-term changes in psychological distress as measured by self-reported symptoms of anxiety, depression, and demoralization one week after psilocybin session.
To measure short-term changes in well-being and quality of life one week after psilocybin session.
To measure changes in neuronal activity associated with psychological changes assessed by functional magnetic resonance imaging (fMRI) during resting state and affective tasks one week after psilocybin session.
To demonstrate safety of psilocybin treatment in participants with pancreas and biliary tract cancers.