Clinical Trial

Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer

Completed Early Phase 1
View on ClinicalTrials.gov →
Summary
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determine the feasibility of enrolling subjects and treatment adherence. The secondary objectives are to describe the safety and tolerability. Exploratory objectives are to assess the effect of ketamine/placebo on Depression, Anxiety, Physical Function, Pain Interference, Pain Intensity, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as measured by PROMIS Anxiety Short Form 7a and the PROMIS-29 Profile v2.1 of Patient Reported Outcomes, as well as changes in circulatory inflammatory cytokines, blood glutamine levels, and other biomarkers of anxiety and/or depression.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-14
notable Enrollment reduced: 20 -> 12 participants 2026-08-14
notable Primary completion moved earlier: 2026-07-15 -> 2026-03-06 2026-08-14
minor Completion moved earlier: 2026-12 -> 2026-03-30 2026-08-14
Trial Details
NCT Number NCT05086250
Lead Sponsor Cedars-Sinai Medical Center
Conditions Anxiety, Pancreatic Cancer
Enrollment 12 participants
Start Date 2022-10-20
Primary Completion 2026-03-06 (estimated)
Study Completion 2026-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13