RecruitingEarly Phase 1NCT05086250

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

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


Sponsor

Cedars-Sinai Medical Center

Enrollment

20 participants

Start Date

Oct 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose oral ketamine can reduce anxiety in people with pancreatic cancer. Ketamine is a medication more commonly known as an anesthetic, but it is increasingly being studied for mental health conditions. This trial explores whether it can help cancer patients who are feeling severely anxious. **You may be eligible if...** - You have been diagnosed with pancreatic cancer - You are currently receiving or recently completed cancer treatment (surgery, chemo, radiation, or immunotherapy) - You have moderate to severe anxiety based on a questionnaire score - You are 18 or older - You can read and understand English - Your liver function is adequate **You may NOT be eligible if...** - You are pregnant or trying to become pregnant - You have a history of psychosis or certain psychiatric conditions that could be worsened by ketamine - You have a history of substance abuse involving ketamine or related drugs - You drive or operate heavy machinery and are unwilling to avoid these activities after taking doses - You have poor liver function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).

DRUGPlacebo

Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).

DRUGPlacebo

Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).

DRUGKetamine

Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT05086250


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