search
Back to results

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

Primary Purpose

Pancreas Cancer, Biliary Tract Cancer, Psychological Distress

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?
  2. Is the participant between the ages of 19 and 85?
  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?
  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?
  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:> 3 X upper limit of normal (ULN) AST: > 3 X ULN ALT:> 3 X ULN Total bilirubin: > 3 X ULN
  10. Does the participant have Renal dysfunction as indicated by creatinine clearance <40 ml/min using the Cockroft-Gault equation?
  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?
  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?

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psilocybin Treatment Arm

Family Observation Group

Arm Description

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

The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.

Outcomes

Primary Outcome Measures

Recruitment Rate
Number of participants enrolled/ number approached.
Retention Rate
Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2022
Last Updated
September 29, 2023
Sponsor
University of Nebraska
Collaborators
Nebraska University Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05220046
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Nebraska University Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Biliary Tract Cancer, Psychological Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants are enrolled as patient/family dyad, with patient in intervention arm and family in observational arm
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin Treatment Arm
Arm Type
Experimental
Arm Description
Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.
Arm Title
Family Observation Group
Arm Type
No Intervention
Arm Description
The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Other Intervention Name(s)
mushroom
Intervention Description
Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of participants enrolled/ number approached.
Time Frame
18 months
Title
Retention Rate
Description
Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose
Description
Patient Health Questionnaire-9 (PHQ-9) is a nine-item, 32 point scale of frequency of common depressive symptoms. Higher score indicates worse depression.
Time Frame
Baseline; Day 8-11 post-dose
Title
Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose
Description
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.
Time Frame
Baseline; Day 8-11 post-dose
Title
Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose
Description
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.
Time Frame
Baseline; Day 8-11 post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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? Is the participant between the ages of 19 and 85? Does the subject have unresectable pancreatic or biliary tract cancer (gallbladder adenocarcinoma, cholangiocarcinoma, ampullary adenocarcinoma carcinoma)? Is the participant English speaking? Does the participant have an ECOG performance status of 0-3? Does the participant have a life expectancy ≥ 8 weeks as determined by referring oncologist? Does the participant have the ability to provide written informed consent and comply with study procedures? Is the participant aware of the neoplastic and likely incurable nature of his/her disease? Does the participant have one family member willing to participate in measures? 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: 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? 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? 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? 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? 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? Does the participant have alcohol or recreational drug abuse disorder, excluding caffeine and nicotine? Does the participant have known CNS metastases or other major CNS disease such as seizure disorder, dementia, Parkinson's disease, multiple sclerosis? Is the participant receiving treatment in another clinical trial involving an investigational product for the treatment of cancer? Does the participant have Hepatic dysfunction as indicated by the following values: Alkaline phosphatase:> 3 X upper limit of normal (ULN) AST: > 3 X ULN ALT:> 3 X ULN Total bilirubin: > 3 X ULN Does the participant have Renal dysfunction as indicated by creatinine clearance <40 ml/min using the Cockroft-Gault equation? 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? Does the participant have a history of seizures? 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? Female participants only: Is the participant pregnant or breastfeeding? 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 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?
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanette L Welsh, ASN
Phone
402-552-3524
Email
tanette.welsh@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tami Braley, APRN
Phone
402-559-8197
Email
tamara.braley@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lou Lukas, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanette L Welsh, ASN
Phone
402-552-3524
Email
tanette.welsh@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs