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Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer

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ClinicalTrials.gov Identifier: NCT05220046
Recruitment Status : Not yet recruiting
First Posted : February 2, 2022
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
Jim Young Pancreatic Cancer Research Memorial Fund
Information provided by (Responsible Party):
Lou Lukas, University of Nebraska

Tracking Information
First Submitted Date  ICMJE January 15, 2022
First Posted Date  ICMJE February 2, 2022
Last Update Posted Date June 22, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2022)
  • Recruitment Rate [ Time Frame: 18 months ]
    Number of participants enrolled/ number approached.
  • Retention Rate [ Time Frame: 24 months ]
    Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2022)
  • Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose [ Time Frame: Baseline; Day 8-11 post-dose ]
    Patient Health Questionnaire-9 (PHQ-9) is a nine-item, 32 point scale of frequency of common depressive symptoms. Higher score indicates worse depression.
  • Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose [ Time Frame: Baseline; Day 8-11 post-dose ]
    Change in General Anxiety DIsorder-7 (GAD-7) is a 7 item, 21 scale to measure frequency of common symptoms of anxiety with higher score indicating higher severity.
  • Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose [ Time Frame: Baseline; Day 8-11 post-dose ]
    Change in Demoralization Scale (D-II) is a 16 item, 32 point scale with two factors, meaning & purpose and distress & coping, that measures frequency of symptoms of demoralization and existential distress, with higher score indicating higher severity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer
Official Title  ICMJE An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress and Improve Quality of Life in Persons With Pancreatobiliary Cancer, With a Parallel Assessment of Healthcare Utilization and Family Wellbeing
Brief Summary The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to inoperable pancreatobilliary cancer. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.
Detailed Description

Participants with unresectable pancreas or biliary tract cancers are eligible for intervention, paired family member recruited for observational arm. Following preparatory sessions in outpatient palliative care clinic or by telehealth (2-4 sessions lasting 60-90 minutes each), psilocybin will be administered as a 25mg capsule during an 8-hour monitored session. Integration sessions (2-3 sessions lasting up to 90 minutes each) will take place in the outpatient palliative care clinic or by phone or tele-heath. Primary and secondary objectives are complete at one-week post treatment, longitudinal exploratory measures collected up to 12 months post baseline.

Parallel assessment of health care utilization, including choices regarding anti-cancer treatment and resource utilization, and family member distress, family communication, well-being and bereavement will be conducted at concurrent time points.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are enrolled as patient/family dyad, with patient in intervention arm and family in observational arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreas Cancer
  • Biliary Tract Cancer
  • Psychological Distress
Intervention  ICMJE Drug: Psilocybin
Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling
Study Arms  ICMJE
  • Experimental: Psilocybin Treatment Arm
    Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.
    Intervention: Drug: Psilocybin
  • No Intervention: Family Observation Group
    The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.
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: January 28, 2022)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. For participants with a diagnosis unresectable pancreatic or biliary tract cancer (gallbladder adenocarcinoma, cholangiocarcinoma, ampullary adenocarcinoma carcinoma), do they have a non-zero score on the NCCN Distress Thermometer? Record Distress score ___________
  2. Is the participant between the ages of 19 and 85? Record age: ________
  3. Does the subject have unresectable pancreatic or biliary tract cancer (gallbladder adenocarcinoma, cholangiocarcinoma, ampullary adenocarcinoma carcinoma)?
  4. Is the participant English speaking?
  5. Does the participant have an ECOG performance status of 0-3? Score:______
  6. Does the participant have a life expectancy ≥ 8 weeks as determined by referring oncologist?
  7. Does the participant have the ability to provide written informed consent and comply with study procedures?
  8. Is the participant aware of the neoplastic and likely incurable nature of his/her disease?
  9. Does the participant have one family member willing to participate in measures?
  10. Is the participant (male and female) of childbearing potential (defined as age <55 and menses within the prior 2 years with intact ovaries and uterus) agreeable to use an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session?

Exclusion Criteria:

  1. Does the participant have severe symptoms of depression or anxiety warranting immediate treatment with antidepressant or anxiolytic medications or preventing safe discontinuation of those medications for the psilocybin session?
  2. Is the participant suicidal, noted by a history of suicide attempt within 2 years or high-risk of suicide as measured by Columbia Suicide Severity? C-SSRS score:_______
  3. Does the participant have a current or prior history of schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder?
  4. Does the participant have a first-degree family member with schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder?
  5. Does the participant have any conditions known to be incompatible with establishment of rapport or safe exposure to psilocybin including dissociative disorder, anorexia nervosa, bulimia nervosa?
  6. Does the participant have alcohol or recreational drug abuse disorder, excluding caffeine and nicotine?
  7. Does the participant have known CNS metastases or other major CNS disease such as seizure disorder, dementia, Parkinson's disease, multiple sclerosis?
  8. Is the participant receiving treatment in another clinical trial involving an investigational product for the treatment of cancer?
  9. Does the participant have Hepatic dysfunction as indicated by the following values: Alkaline phosphatase: _____ AST: _____ ALT:_____ Total bilirubin: ________ NOTE: Participants with baseline hepatic dysfunction which their treating physician expects will improve to meet the criteria defined above following cancer treatment and/or other intervention (ie. biliary stent) are eligible; the above criteria must be met prior to administration of psilocybin
  10. Does the participant have Renal dysfunction as indicated by creatinine clearance <40 ml/min using the Cockroft-Gault equation? Creat. Clr: ______
  11. Does the participant have cardiac or circulatory dysfunction defined as: uncontrolled hypertension (systolic blood pressure > 140 or diastolic blood pressure >90 mmHg on three separate readings), angina, stroke or myocardial infarction in the prior 6 months, claudication?
  12. Does the participant have a history of seizures?
  13. Is the participant unable to skip a meal (lunch), or diabetes which requires administration of medication more than twice daily, or with symptomatic hypoglycemia within the prior 30 days?
  14. Female participants only: Is the participant pregnant or breastfeeding? Pregnancy test date: __________ Result: ________
  15. Is the participant currently using any of the following potent metabolic inducers or inhibitors? Inducers: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, St. Johns Wort. Paclitaxel and dexamethasone are permitted if 5 half-lives have passed between last dose and psilocybin session Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin
  16. MMRI exclusions: Metal in body (i.e. hearing aid, cardiac pacemaker, bone plates, braces, non-removeable piercings/implants, etc.) claustrophobia, inability to lay still for one-hour, or any other condition that would preclude MRI scanning?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05220046
Other Study ID Numbers  ICMJE 860-21
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
Plan to Share IPD: No
Current Responsible Party Lou Lukas, University of Nebraska
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lou Lukas
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jim Young Pancreatic Cancer Research Memorial Fund
Investigators  ICMJE Not Provided
PRS Account University of Nebraska
Verification Date June 2022

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