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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086250
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE October 8, 2021
First Posted Date  ICMJE October 20, 2021
Last Update Posted Date November 3, 2021
Estimated Study Start Date  ICMJE December 2021
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2021)
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. [ Time Frame: 2 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
Feasibility of enrolling subjects in an anxiety treatment trial comparing oral ketamine vs placebo in patients with pancreatic cancer and anxiety receiving or within twelve weeks of having received cancer targeted treatment. [ Time Frame: 2 months ]
Proportion of patients dropping out of study for any reason prior to end of treatment visit. The following will also be collected:
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2021)
  • 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. [ Time Frame: 3 months ]
    Th number of adverse events related to study treatment assessed per CTCAE v.5.
  • 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. [ Time Frame: 3 months ]
    This is a self-report tool that provides patient rating (none, mild, moderate, severe) of 33 potential side effects of ketamine. The Adverse Symptom Checklist (ASC) is scored 0 (none), mild (1), moderate (2), and severe (3 points). This scale also asks patients to quantify side effect interference in daily activities, also scored the same way (Min value 0, Max Value 3). Therefore, the total score for the ASC has Min value 0, Max 102 where total higher scores mean a worse outcome. The ASC responses will be dichotomized (frequency: 0%-25% vs >25%; intensity: none, mild vs moderate, or greater; burden: none to mild impairment vs moderate or greater impairment) and will be descriptively summarized by each treatment arm at each assessment time point.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
  • To investigate the safety of oral ketamine in patients with pancreatic cancer and anxiety receiving or within twelve weeks of having received cancer targeted treatment. [ Time Frame: 3 months ]
    Number of adverse events related to study treatment as assessed per CTCAE v.5
  • To investigate the tolerability of oral ketamine in patients with pancreatic cancer and anxiety receiving or within twelve weeks of having received cancer targeted treatment. [ Time Frame: 3 months ]
    Patient-reported Ketamine Adverse Symptom Checklist and Impact scores. This is a self-report tool that provides patient rating (none, mild, moderate, severe) of 33 potential side effects of ketamine. This scale also asks patients to quantify side effect interference in daily activities, overall frequency of side effects, and overall intensity of side effects. The ASC responses will be dichotomized (frequency: 0%-25% vs >25%; intensity: none, mild vs moderate, or greater; burden: none to mild impairment vs moderate or greater impairment) and will be descriptively summarized by each treatment arm at each assessment time point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:

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.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety
  • Pancreatic Cancer
Intervention  ICMJE
  • Drug: Ketamine
    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).
    Other Name: Ketalar
  • Drug: Placebo
    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: Placebo
    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: Ketamine
    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).
    Other Name: Ketalar
Study Arms  ICMJE
  • Experimental: Arm A: Ketamine Followed by Placebo
    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).
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
  • Experimental: Arm B: Placebo Followed by Ketamine
    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).
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mehrnoosh Nassaj, MS, CCRP, CHRC 310-423-7735 Mehrnoosh.Nassaj@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05086250
Other Study ID Numbers  ICMJE IIT2019-18-IRWIN-KETANX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Irwin, MD, PhD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP