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NMDA Receptor Antagonist
Oral Ketamine for Anxiety in Pancreatic Cancer Patients
Phase < 1
Recruiting
Led By Scott Irwin, MD, PhD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented adequate liver function within the screening period
Participant has been diagnosed with pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing whether ketamine or a placebo can help treat anxiety in cancer patients who are receiving or have recently received cancer targeted therapy. The study will look at feasibility, safety, and tolerability, and also at the effect of ketamine/placebo on things like depression, anxiety, pain, fatigue, and sleep disturbance.
Who is the study for?
Adults with pancreatic cancer and moderate to severe anxiety, currently or recently treated for cancer, can join. They must understand English, agree to use contraception if needed, avoid alcohol and driving post-medication. Those on stable antidepressants may qualify but not if they have certain psychiatric conditions, high suicide risk, ketamine allergy, severe heart issues or uncontrolled blood pressure.Check my eligibility
What is being tested?
This study tests oral ketamine against a placebo in reducing anxiety among pancreatic cancer patients. It's a double-blind trial where neither the participants nor the researchers know who gets what treatment until after the results are collected. The effects on mood, physical function and inflammation markers will be measured.See study design
What are the potential side effects?
Ketamine might cause side effects like disorientation or confusion shortly after taking it; hence driving is restricted post-dose. Other possible side effects include increased blood pressure and heart rate changes which will be closely monitored due to the patient population.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well, as confirmed by recent tests.
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I have been diagnosed with pancreatic cancer.
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I am 18 years old or older.
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I have been diagnosed with pancreatic cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of enrolling subjects which will be measured by the proportion of patients dropping out of study for any reason prior to the end of treatment visit.
Secondary outcome measures
To investigate the safety of oral ketamine in patients with pancreatic cancer and anxiety, which will be assessed by the number of adverse events related to study treatment per CTCAE v.5.
Anxiety
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Placebo Followed by KetamineExperimental Treatment2 Interventions
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).
Group II: Arm A: Ketamine Followed by PlaceboExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,879 Total Patients Enrolled
3 Trials studying Anxiety
262 Patients Enrolled for Anxiety
Scott Irwin, MD, PhDPrincipal InvestigatorCedars-Sinai Medical Center
3 Previous Clinical Trials
364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure has been over 180/100 twice in the last two months.My liver is functioning well, as confirmed by recent tests.I have been diagnosed with pancreatic cancer.I haven't taken MAOI drugs in the last 14 days.I have recently had or am currently undergoing treatment for cancer.I am currently receiving or have recently had treatment for cancer.I am not pregnant or nursing, and if I can have children, I agree to use birth control during the trial.I have been diagnosed with dementia.I am using or willing to use birth control and, if applicable, have a negative pregnancy test.I can avoid driving or using machines after my medication until I've had a good sleep.You have had bad allergic reactions to ketamine in the past.My thyroid condition is not under control.I have an aneurysm or arteriovenous malformation.You have a high score on the Suicidal Risk Assessment (SRA).I've been on the same antidepressant dose for 12 weeks.I do not have severe heart rhythm problems or chest pain.I have a severe heart condition that is not currently under control.You have moderate to severe anxiety based on specific tests.I've been on the same antidepressant dose for 12 weeks or more.I am 18 years old or older.You have high levels of anxiety based on specific tests.I have been diagnosed with pancreatic cancer.You have been diagnosed with schizophrenia, bipolar disorder, delirium, or psychosis according to the MINI International Neuropsychiatric Interview (MINI Plus).I was diagnosed with cancer less than 6 weeks ago.I have had a brain bleed in the past.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Ketamine Followed by Placebo
- Group 2: Arm B: Placebo Followed by Ketamine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety Patient Testimony for trial: Trial Name: NCT05086250 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial currently accessible to participants?
"Affirmative. Clinicaltrials.gov's records reflect that this research has been actively looking for participants since October 20th 2022 and is still recruiting as of the 26th, with a goal to enroll 20 patients from one site."
Answered by AI
How many participants are registered for this experiment?
"Indeed, the clinicaltrials.gov website attests that this medical trial is actively seeking volunteers. It was initially posted on October 20th 2022 and most recently revised on October 26th of the same year. The study requires a total of 20 participants from 1 research site."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
California
How old are they?
18 - 65
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am hoping i can help reduce my lifelong anxiety. Ive used many other natural methods but it hasnt been effective for the longterm.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
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