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

NCT05086250 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT2019-18-IRWIN-KETANX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Pancreatic Cancer

Keywords

ketamine; placebo

Outcome Measures

Primary Outcomes (1)

• 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.

  The following will be collected as part of this feasibility measurement: * Reasons for dropout. * Proportion of patients pre-screened that were potentially eligible for study participation. * Proportion of patients that were potentially eligible who were approached. * Proportion of approached patients that decline study participation and why. * Proportion of approached patients that agreed to participate. * Proportion of approached that were randomized. * Proportion of patients completing study through End of Treatment visit and each follow-up visit.

  2 months

Secondary Outcomes (2)

• 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.

  3 months

• To investigate the tolerability of oral ketamine in patients with pancreatic cancer and anxiety, which will be measured by patient-reported Ketamine Adverse Symptom Checklist and Impact scores.

  3 months

Study Arms (2)

Arm A: Ketamine Followed by Placebo

EXPERIMENTAL

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).

Drug: Ketamine; Drug: Placebo

Arm B: Placebo Followed by Ketamine

EXPERIMENTAL

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).

Drug: Placebo; Drug: Ketamine

Interventions

Placebo DRUG

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).

Arm A: Ketamine Followed by Placebo

Ketamine DRUG

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).

Also known as: Ketalar

Arm A: Ketamine Followed by Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pancreatic Neoplasms

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Mental Disorders; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Scott Irwin, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Navigator

CONTACT

310-423-8887; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, research staff, or subjects. The following study procedures will be in place to ensure double-blind administration of study treatments. * Access to the randomization code will be strictly controlled * Packaging and labeling of test and control treatments will be identical to maintain the blind The research pharmacist will manage the investigational agent. The blind will be maintained through the effort of the research pharmacist and the pharmacy. Unblinding will only occur when it is deemed medically necessary. The date and reason for breaking the blind will be documented.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Patient and Family Support Program

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 20, 2021
• Study Start: October 20, 2022
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)