What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as chemotherapy, targeted therapies (e.g., small molecule inhibitors and monoclonal antibodies), and immunotherapy, often result in side effects like fatigue, nausea, diarrhea, cytopenias, and skin toxicities. Specific drugs like hydroxyurea can cause mucocutaneous ulcers, peripheral neuropathy, and potential teratogenicity, while ruxolitinib may lead to anemia and elevated liver enzymes. Psilocybin, being studied for its potential benefits in cancer survivors, primarily targets psychological symptoms such as anxiety and depression, with its side effects still under evaluation.

What prior FDA approvals exist?

FDA approvals for the treatment of blood cancers have primarily focused on chemotherapeutic agents, targeted therapies, and immunotherapies. For example, azacitidine and decitabine are hypomethylating agents approved for myelodysplastic syndromes and acute myeloid leukemia. While these drugs target the cancer cells directly, there is also a growing interest in supportive care treatments to manage symptoms and improve quality of life. Psilocybin, a serotonin receptor agonist, is being studied for its potential to alleviate demoralization and chronic pain in cancer survivors, highlighting the importance of addressing psychological well-being in cancer care.

What other types of research exist?

Promising novel alternatives to psilocybin for blood cancer patients include: 1) CAR-T cell therapy, which has shown significant success in treating certain types of blood cancers like B-cell lymphomas and acute lymphoblastic leukemia. 2) Bispecific T-cell engagers (BiTEs), such as blinatumomab, which have demonstrated efficacy in targeting cancer cells. 3) JAK inhibitors, like ruxolitinib, which are used in the treatment of myeloproliferative neoplasms. 4) BCL-2 inhibitors, such as venetoclax, which have been effective in treating chronic lymphocytic leukemia and acute myeloid leukemia. These therapies represent significant advancements in the treatment of blood cancers and offer new hope for patients.

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Psychedelic

Psilocybin Therapy for Cancer-related Chronic Pain

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

Common treatments for blood cancers include chemotherapy, targeted therapies, and immunotherapy. Chemotherapy agents like anthracyclines and cytarabine work by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors, block specific proteins that promote cancer cell growth. Immunotherapy harnesses the body's immune system to recognize and destroy cancer cells. Psilocybin, a serotonin receptor agonist, is being studied for its potential to alleviate psychological distress in cancer patients, which is crucial for improving overall quality of life and treatment adherence. Understanding these mechanisms helps tailor treatments to effectively combat blood cancers while addressing the holistic needs of patients.

Phase 1

Waitlist Available

Led By Ali J. Zarrabi, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 98 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if psilocybin can safely help cancer survivors who feel hopeless and have chronic pain. Psilocybin changes brain perception to improve mood and reduce pain. Psilocybin has been studied since the 1960s for its potential to treat cancer-related psychiatric distress, showing promise in improving depression and anxiety.

Who is the study for?

This trial is for cancer survivors aged 26-85 with a life expectancy over six months, experiencing chronic pain and demoralization. They must have been diagnosed at least a year ago and have someone to care for them post-treatment. Exclusions include non-English speakers, substance abuse, certain medical conditions like seizures or severe heart disease, BMI <=18, renal insufficiency, use of specific drugs including SSRIs/SNRIs/MAOIs or efavirenz.

What is being tested?

The trial tests the effects of psilocybin in combination with palliative psychotherapy on demoralized cancer survivors with chronic pain. It aims to see if this treatment can alleviate anxiety, depression and improve quality of life.

What are the potential side effects?

Possible side effects may include temporary changes in perception and mood swings during psilocybin administration. Long-term side effects are being studied but could involve similar psychological reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 98 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 98 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 98 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluation of Feasibility Outcome To Assess Patient Retention in The Study

Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher

Other study objectives

Anxiety and Depression at Forty-Two Days

Anxiety

Caregiver strain at Forty-Two Days

+21 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (psilocybin, observation)Experimental Treatment4 Interventions

Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

Psychotherapy

2014

Completed Phase 3

~3440

Do I qualify?Apply below to find out

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

Common treatments for blood cancers include chemotherapy, targeted therapies, and immunotherapy. Chemotherapy agents like anthracyclines and cytarabine work by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors, block specific proteins that promote cancer cell growth. Immunotherapy harnesses the body's immune system to recognize and destroy cancer cells. Psilocybin, a serotonin receptor agonist, is being studied for its potential to alleviate psychological distress in cancer patients, which is crucial for improving overall quality of life and treatment adherence. Understanding these mechanisms helps tailor treatments to effectively combat blood cancers while addressing the holistic needs of patients.

Population-based meta-analysis of bortezomib exposure-response relationships in multiple myeloma patients.Randomized multicenter phase II trial of subcutaneous recombinant human interleukin-12 versus interferon-alpha 2a for patients with advanced renal cell carcinoma.