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

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Brief Title

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

Official Title

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Recruitment Rate

Secondary Outcome

 Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose

Condition

Pancreas Cancer

Intervention

Psilocybin

Study Arms / Comparison Groups

 Psilocybin Treatment Arm
Description:  Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

September 2022

Completion Date

April 2025

Primary Completion Date

April 2024

Eligibility Criteria

        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?
      

Gender

All

Ages

19 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT05220046

Organization ID

860-21


Responsible Party

Sponsor-Investigator

Study Sponsor

Lou Lukas

Collaborators

 Jim Young Pancreatic Cancer Research Memorial Fund

Study Sponsor

, , 


Verification Date

June 2022