Could a low dose of ketamine ease anxiety in pancreatic cancer?
NCT ID NCT05086250
First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This study tests whether a low dose of oral ketamine can safely help with anxiety in people with pancreatic cancer. Twenty participants will receive both ketamine and a placebo at different times to compare effects. The main goal is to see if such a study is even possible, not to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketamine
- What this could lead to
- If this works, it could point toward a new way to manage anxiety in people with pancreatic cancer.
- What could go wrong
- This is a very early, small study with only 20 people. It is designed mainly to see if the idea is feasible, not to prove ketamine works. Side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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12 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
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Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent. 2. Participant has been diagnosed with pancreatic cancer. 3. Receiving or within twelve weeks of having received cancer targeted treatment, including surgery, radiation, chemotherapy, immunotherapy, or other cancer targeted therapy. 4. Age ≥ 18 years. 5. Has moderate to severe anxiety according to the PROMIS Anxiety Short Form 7a and/or PROMIS-29 anxiety module (T-score of \> 60). 6. Documented adequate liver function within the screening period. 7. Use of concomitant standard antidepressants targeting anxiety (e.g. SSRIs) is permitted if dose has been the same for at least 12 weeks prior to study entry and patient still meets inclusion #5. 8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and while receiving study drug. Women of child-bearing potential must have a negative urine or blood pregnancy test at screening. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study staff immediately. 9. Must be able to read and understand English. 10. Required not to engage in potentially hazardous activities, such as driving a motor vehicle or operating machinery, after receiving a medication dose until the next day after a restful sleep (as per recommendations with Spravato). 11. Agrees to abstain from alcohol use while taking study medication. Exclusion Criteria: 1. Initial cancer diagnosis ≤6 weeks prior to Day 0. 2. Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis. 3. Scores ≥ 10 on the Suicidal Risk Assessment (SRA). 4. History of allergic reactions or hypersensitivity to ketamine. 5. Documented history of severe cardiac insufficiency (NYHA III or IV), with currently uncontrolled and/or unstable cardiac or coronary artery disease. 6. Current or recent significant tachyarrhythmia, severe angina, or myocardial ischemia, as assessed by a study physician. 7. Documented history of poorly controlled hypertension (Systolic Blood Pressure \> 180 mmHG or Diastolic Blood Pressure \> 100 mmHG twice within a one-month period in last two months), with or without antihypertensives. 8. Women who are pregnant or nursing or expect to become pregnant or start nursing during the expected trial duration, and women of childbearing potential who refuse to use contraceptives to prevent childbearing. 9. Uncontrolled hypo- or hyperthyroidism, as assessed by a study physician. 10. Diagnosis of dementia. 11. Treatment with monoamine oxidase inhibitor (MAOI) within 14 days of Day 0. 12. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. 13. History of intracerebral hemorrhage. 14. Refusal/inability to comply with inclusion criterion #10 (driving restrictions) and inclusion criterion #11 (alcohol abstinence) during study treatment period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Other studies related to the condition(s) this trial covers.
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