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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2023
  • participants needed
    20
  • sponsor
    Cedars-Sinai Medical Center
Updated on 20 September 2022
cancer chemotherapy

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.

Details
Condition Anxiety, Pancreatic Cancer
Treatment Ketamine, Placebo
Clinical Study IdentifierNCT05086250
SponsorCedars-Sinai Medical Center
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent
Participant has been diagnosed with pancreatic cancer
Receiving or within twelve weeks of having received cancer targeted treatment, including surgery, radiation, chemotherapy, immunotherapy, or other cancer targeted therapy
Age ≥ 18 years
Has moderate to severe anxiety according to the PROMIS Anxiety Short Form 7a and/or PROMIS-29 anxiety module (T-score of > 60)
Documented adequate liver function within the screening period
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
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
Must be able to read and understand English
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)
Agrees to abstain from alcohol use while taking study medication

Exclusion Criteria

Initial cancer diagnosis ≤6 weeks prior to Day 0
Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis
Scores ≥ 10 on the Suicidal Risk Assessment (SRA)
History of allergic reactions or hypersensitivity to ketamine
Documented history of severe cardiac insufficiency (NYHA III or IV), with currently uncontrolled and/or unstable cardiac or coronary artery disease
Current or recent significant tachyarrhythmia, severe angina, or myocardial ischemia, as assessed by a study physician
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
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
Uncontrolled hypo- or hyperthyroidism, as assessed by a study physician
Diagnosis of dementia
Treatment with monoamine oxidase inhibitor (MAOI) within 14 days of Day 0
Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation
History of intracerebral hemorrhage
Refusal/inability to comply with inclusion criterion #10 (driving restrictions) and inclusion criterion #11 (alcohol abstinence) during study treatment period
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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