What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine combined with nab-paclitaxel, often result in side effects including neutropenia, fatigue, neuropathy, diarrhea, and nausea. These treatments can significantly impact the patient's quality of life. In contrast, psilocybin, a psychoactive compound under investigation for reducing psychological distress in cancer patients, may offer a different side effect profile, primarily involving transient psychological effects such as altered perception and mood changes, rather than the severe physical side effects associated with traditional chemotherapy.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer primarily include chemotherapeutic agents such as gemcitabine, nab-paclitaxel, and combination regimens like FOLFIRINOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan). These treatments focus on prolonging survival and managing symptoms rather than addressing psychological distress directly. Psilocybin, a psychoactive compound, is being studied for its potential to alleviate psychological distress in cancer patients, but it is not yet FDA-approved for this purpose. Currently, there are no FDA-approved psychoactive drugs specifically for the treatment of psychological distress in pancreatic cancer patients.

What other types of research exist?

Promising alternatives to psilocybin for alleviating psychological distress in pancreatic cancer patients include medical cannabis or cannabinoids, which have shown potential in managing neuropathic pain and psychological symptoms. Additionally, acupuncture/acupressure and certain antidepressants like SNRIs (e.g., duloxetine) may also be considered for their benefits in managing psychological distress and associated symptoms in cancer patients.

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Psychedelic

Psilocybin for Psychological Distress in Pancreatic and Biliary Tract Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, but it can also affect healthy cells, leading to significant side effects. Targeted therapy involves drugs that specifically target cancer cell molecules, such as proteins or genes, that are involved in the growth and survival of cancer cells, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells. These treatments are crucial for pancreatic cancer patients due to the aggressive nature of the disease and its tendency to be diagnosed at an advanced stage. Psilocybin, a psychoactive compound, is being studied for its potential to alleviate psychological distress in these patients, which is important as mental health significantly impacts overall treatment outcomes and quality of life.

Phase 1

Recruiting

Led By Lou Lukas, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant (male and female) of childbearing potential (defined as age <55 and menses within the prior 2 years with intact ovaries and uterus) must agree to use an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session

Participant must have an ECOG performance status of 0-3

Must not have

Participant must have cardiac or circulatory dysfunction defined as specific conditions

Female participant must not be pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a psilocybin-based treatment to help patients with inoperable pancreas or biliary tract cancers feel less distressed. Psilocybin, found in certain mushrooms, can change brain activity to improve mood and reduce anxiety. The study will also look at how this treatment affects patients' families. Psilocybin has been historically used for ritualistic, recreational, and medicinal purposes, with recent studies recognizing its potential to treat depression and anxiety.

Who is the study for?

This trial is for adults aged 19-85 with inoperable pancreatic or biliary tract cancer experiencing distress. They must speak English, have a life expectancy of at least 8 weeks, and be able to consent to the study. A family member must also participate. Exclusions include severe depression/anxiety, substance abuse, certain medical conditions like CNS metastases or major organ dysfunction, and those on specific medications.

What is being tested?

The trial tests psilocybin's effect on psychological distress in patients with inoperable pancreatobiliary cancer. It aims to recruit participants and their family members (observational arm) to measure changes in distress levels before and after treatment over time.

What are the potential side effects?

While not explicitly listed here, common side effects of psilocybin may include altered sensory experiences, mood changes, nausea, headache, increased heart rate and blood pressure which can vary based on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 55, had a menstrual cycle in the last 2 years, and agree to use birth control during the study.

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I can care for myself but may not be able to do heavy physical work.

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My cancer in the pancreas or bile ducts cannot be removed by surgery.

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I am between 19 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart or blood circulation problems.

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I am not pregnant or breastfeeding.

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I have a close family member with schizophrenia, psychotic disorder, or bipolar disorder.

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I am not currently taking any strong drugs that affect how my body processes medications.

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My kidney function is low, with a creatinine clearance under 40 ml/min.

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I have brain metastases or a major brain condition like Parkinson's.

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My liver is not functioning properly.

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I need immediate treatment for severe depression or anxiety and cannot safely stop my medication for a psilocybin session.

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I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recruitment Rate

Retention Rate

Secondary study objectives

Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose

Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose

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

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Psilocybin Treatment ArmExperimental Treatment1 Intervention

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

Group II: Family Observation GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, but it can also affect healthy cells, leading to significant side effects. Targeted therapy involves drugs that specifically target cancer cell molecules, such as proteins or genes, that are involved in the growth and survival of cancer cells, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells. These treatments are crucial for pancreatic cancer patients due to the aggressive nature of the disease and its tendency to be diagnosed at an advanced stage. Psilocybin, a psychoactive compound, is being studied for its potential to alleviate psychological distress in these patients, which is important as mental health significantly impacts overall treatment outcomes and quality of life.