Actively Recruiting
Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
Led by Cedars-Sinai Medical Center · Updated on 2026-05-08
20
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Diagnosed with pancreatic cancer
- Receiving or within 12 weeks of cancer targeted therapy including surgery, radiation, chemotherapy, immunotherapy, or other treatments
- Age 18 years or older
- Moderate to severe anxiety by PROMIS Anxiety Short Form 7a and/or PROMIS-29 anxiety module (T-score > 60)
- Adequate liver function documented during screening
- Stable dose of antidepressants targeting anxiety for at least 12 weeks before study entry allowed
- Agree to use contraception if of child-bearing potential and have negative pregnancy test if applicable
- Able to read and understand English
- Agree not to drive or operate machinery until the next day after restful sleep post medication dose
- Agree to abstain from alcohol while taking study medication
You will not qualify if you...
- Initial cancer diagnosis within 6 weeks before Day 0
- Diagnosed with schizophrenia, bipolar disorder, delirium, or psychosis based on MINI Plus
- Suicidal Risk Assessment score 10 or higher
- History of allergic reaction or hypersensitivity to ketamine
- Severe cardiac insufficiency (NYHA III or IV) or uncontrolled cardiac/coronary artery disease
- Current or recent serious heart rhythm problems, severe angina, or myocardial ischemia
- Poorly controlled hypertension (systolic >180 mmHG or diastolic >100 mmHG twice in last two months)
- Pregnant, nursing, or unwilling to use contraception if of childbearing potential
- Uncontrolled thyroid disorders
- Diagnosis of dementia
- Treatment with monoamine oxidase inhibitors within 14 days before Day 0
- Aneurysmal vascular disease or arteriovenous malformation
- History of intracerebral hemorrhage
- Unable or unwilling to comply with driving and alcohol restrictions during treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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