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

Launched by CEDARS-SINAI MEDICAL CENTER · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called oral ketamine can help reduce anxiety in patients with pancreatic cancer. The trial is specifically looking at patients who are currently receiving treatment for their cancer or have finished treatment within the last 12 weeks. To be eligible, participants need to be at least 18 years old, have moderate to severe anxiety, and be able to understand and sign consent forms. They should also have good liver function and be stable on any standard antidepressants if they are taking them.

Participants in the trial will receive either ketamine or a placebo (a dummy pill that looks like the real medication but has no active ingredients) in a random order during the study. This means that neither the participants nor the doctors will know which one they are receiving at any given time. The researchers will monitor how well participants tolerate the treatment and gather information on its safety. Additionally, they will look at various factors such as depression, physical function, pain, and sleep quality, using specific questionnaires. It’s important to note that participants will need to avoid alcohol and refrain from certain activities, like driving, after taking the medication. Overall, this study aims to see if using oral ketamine is a feasible approach to managing anxiety in these patients.

Gender

ALL

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.