ACTIVE_NOT_RECRUITING

Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers

Conditions

Pancreas Cancer Biliary Tract Cancer Psychological Distress Gastrointestinal Cancer inoperable unresectable stage IV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.

Official Title

An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers

Quick Facts

Study Start:2023-04-10

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05220046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Between the ages of 19 and 85 * Has stage IV or unresectable GI malignancy * Resides within a 170-mile radius of Omaha, NE * Speaks English * Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Life expectancy ≥ 8 weeks as determined by referring oncologist * Ability to provide written informed consent and comply with study procedures * Awareness of the neoplastic and likely incurable nature of his/her disease * Has one family member willing to participate in measures * Agreeable to using an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session (male and female participant of childbearing potential, defined as age \<55 and menses within the prior 2 years with intact ovaries and uterus) * Negative pregnancy test result (female participants)	* Long-term or unstable psychiatric illness that would prevent safe cessation of psychotropic drugs including MAOIs, lithium, or anti-psychotics * Severe symptoms of depression or anxiety warranting immediate impatient evaluation or treatment * High-risk of suicide, as measured by Columbia Suicide Severity rating Scale * Current or prior history of schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder * First-degree family member with schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder * Conditions known to be incompatible with establishment of rapport or safe exposure to psilocybin including dissociative disorder, borderline personality, traumatic brain injury, obsessive compulsive disorder, anorexia nervosa, or bulimia nervosa * Alcohol or recreational drug abuse disorder, excluding caffeine and nicotine * Known CNS metastases or other major CNS disease such as seizure disorder, dementia, Parkinson's disease, multiple sclerosis * Receive treatment in another clinical trial involving an investigational product for the treatment of cancer during the interventional stage of the protocol * Advanced hepatic dysfunction as indicated by a Child-Pugh Score of C * Renal dysfunction as indicated by creatinine clearance \<40 ml/min using the Cockroft-Gault equation * 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, or claudication * History of seizures * Unable to skip a meal (lunch), or have diabetes which requires administration of medication more than twice daily, or with symptomatic hypoglycemia within the prior 30 days * Pregnant or breastfeeding * Currently using any of the following potent metabolic inducers or inhibitors * Inducers: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, St. Johns Wort, or Paclitaxel and dexamethasone (latter two permitted if 5 half-lives have passed between last dose and psilocybin session) * Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin * 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

Inclusion Criteria

Exclusion Criteria

* Between the ages of 19 and 85
* Has stage IV or unresectable GI malignancy
* Resides within a 170-mile radius of Omaha, NE
* Speaks English
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* Life expectancy ≥ 8 weeks as determined by referring oncologist
* Ability to provide written informed consent and comply with study procedures
* Awareness of the neoplastic and likely incurable nature of his/her disease
* Has one family member willing to participate in measures
* Agreeable to using an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session (male and female participant of childbearing potential, defined as age \<55 and menses within the prior 2 years with intact ovaries and uterus)
* Negative pregnancy test result (female participants)

* Long-term or unstable psychiatric illness that would prevent safe cessation of psychotropic drugs including MAOIs, lithium, or anti-psychotics
* Severe symptoms of depression or anxiety warranting immediate impatient evaluation or treatment
* High-risk of suicide, as measured by Columbia Suicide Severity rating Scale
* Current or prior history of schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder
* First-degree family member with schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder
* Conditions known to be incompatible with establishment of rapport or safe exposure to psilocybin including dissociative disorder, borderline personality, traumatic brain injury, obsessive compulsive disorder, anorexia nervosa, or bulimia nervosa
* Alcohol or recreational drug abuse disorder, excluding caffeine and nicotine
* Known CNS metastases or other major CNS disease such as seizure disorder, dementia, Parkinson's disease, multiple sclerosis
* Receive treatment in another clinical trial involving an investigational product for the treatment of cancer during the interventional stage of the protocol
* Advanced hepatic dysfunction as indicated by a Child-Pugh Score of C
* Renal dysfunction as indicated by creatinine clearance \<40 ml/min using the Cockroft-Gault equation
* 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, or claudication
* History of seizures
* Unable to skip a meal (lunch), or have diabetes which requires administration of medication more than twice daily, or with symptomatic hypoglycemia within the prior 30 days
* Pregnant or breastfeeding
* Currently using any of the following potent metabolic inducers or inhibitors
* Inducers: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, St. Johns Wort, or Paclitaxel and dexamethasone (latter two permitted if 5 half-lives have passed between last dose and psilocybin session)
* Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin
* 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

Contacts and Locations

Principal Investigator

Lou Lukas, MD

PRINCIPAL_INVESTIGATOR

University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: University of Nebraska

Lou Lukas, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-04-10

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

inoperable
unresectable
stage IV

Additional Relevant MeSH Terms

Pancreas Cancer
Biliary Tract Cancer
Psychological Distress
Gastrointestinal Cancer