Using oral ketamine to treat anxiety in pancreatic cancer patients

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

This study is testing if oral ketamine can help reduce anxiety in people with pancreatic cancer who are currently receiving or have recently received treatment.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05086250 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, double-blind, randomized, crossover feasibility study comparing oral ketamine to a placebo for treating anxiety in patients diagnosed with pancreatic cancer. Participants must be currently receiving or have received cancer-targeted therapy within the last 12 weeks. The study aims to assess the feasibility of enrollment and treatment adherence, while also evaluating safety and tolerability. Additionally, it will explore the effects of ketamine on various aspects of mental and physical health, including depression, pain, fatigue, and social participation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with pancreatic cancer who are experiencing moderate to severe anxiety.

Not a fit: Patients with mild anxiety or those not currently undergoing cancer-targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment option for managing anxiety in patients with pancreatic cancer.

How similar studies have performed: While the use of ketamine for anxiety is being explored, this specific approach in pancreatic cancer patients is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Scott Irwin, MD, PhD — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Navigator

Conditions Anxiety; Pancreatic Cancer; ketamine; placebo