Psilocybin therapy for women with breast and ovarian cancer to reduce fear of recurrence

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission

This study is testing if psilocybin therapy can help women with breast and ovarian cancer feel less afraid of their cancer coming back.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT06430541 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of psilocybin-assisted psychotherapy on women with early-stage breast cancer and late-stage ovarian cancer who are in remission. Participants will undergo preparatory therapy before receiving a moderate dose of psilocybin in a controlled environment. Following the dosing, they will engage in four sessions of integrative therapy and complete various survey measures to assess changes in fear of recurrence, anxiety, depression, and overall quality of life. The study aims to determine if this innovative approach can effectively alleviate psychological distress related to cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates include women aged 21 and older with early-stage breast cancer in remission or late-stage ovarian cancer in remission.

Not a fit: Patients with active cancer or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce fear of cancer recurrence and improve mental health outcomes for patients.

How similar studies have performed: While psilocybin-assisted therapy is a novel approach in this context, similar studies have shown promising results in treating anxiety and depression in other populations.

Eligibility criteria

Inclusion Criteria:

1, Aged ≥ 21 2. Diagnosis of:

* early-stage breast cancer at low risk of recurrence

  * defined as clinical stage 1 or 2
  * completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago
  * oncologist reported risk of recurrence at 10 years \< 20%
* late-stage ovarian cancer at high risk of recurrence

  * defined as Clinical stage 3 or 4
  * currently in remission
  * oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as:
* Eastern Cooperative Oncology Group (ECOG) ≤1
* Palliative Performance Scale (PPS) ≥60%
* Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person
* Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.

Exclusion Criteria:

1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:

   * Congestive heart failure
   * Valvular heart disease
   * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450)
   * Recent acute myocardial infarction or evidence of ischemia
   * Malignant hypertension
   * Congenital long QT syndrome
   * Acute renal failure
   * Severe hepatic impairment
   * Respiratory failure
   * eGFR \< 50 mL/min/1.73m2
   * LFTs \> 1.5 x ULN
   * WBC \< 5 x 10\*9/L
   * Hemoglobin \< 8.0 g/dL
   * Platelets \< 150 x 10\*9/L
2. Risk for hypertensive crisis defined as:

   Screening and Baseline blood pressure \>140/90 mmHg
3. Significant central nervous system (CNS) pathology

   Examples include:
   * Primary or secondary cerebral neoplasm
   * Epilepsy
   * History of stroke
   * Cerebral aneurysm
   * Dementia
   * Delirium
4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:

   * Schizophrenia spectrum disorders
   * Schizoaffective disorder
   * Bipolar I or bipolar II disorder
   * Major Depressive Disorder with psychotic features
   * Prior history of psychosis due to medical condition or substance use
5. Family history of psychotic or serious bipolar spectrum illnesses.

   Examples include first-degree relative with:
   * Schizophrenia spectrum disorders
   * Schizoaffective disorder
   * Bipolar I disorder with psychotic features
6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:

   * Agitation
   * Violent behavior
7. Active substance use disorders (SUDs) defined as:

   * DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
   * DAST-10 score of 3 or higher
   * Two or more "yes" responses to CAGE screening questionnaire
8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:

   * Any use in the last 12 months
   * \>25 lifetime uses
9. Clinically significant suicidality or high risk of completed suicide defined as:

   * 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
   * Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
   * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
10. History of hallucinogen persisting perception disorder (HPPD)
11. Pregnancy/lactation
12. Cognitive impairment as defined by:

    • Montreal Cognitive Assessment Test (MoCA) \< 23
13. Concurrent Medications

    * Antidepressants
    * Centrally-acting serotonergic agents (e.g., MAO inhibitors)
    * Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
    * Antipsychotics (e.g., first and second generation)
    * Mood stabilizers (e.g., lithium, valproic acid)
    * Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
    * Significant inhibitors of UGT 1A0 or UGT

      1A10
    * Efavirenz
14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP).
15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
17. Have an allergy or intolerance to any of the materials contained in the drug product
18. Non-English speaking individual
19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

Where this trial is running

Aurora, Colorado and 1 other locations

• Outpatient CTRC — Aurora, Colorado, United States (Recruiting)
• University of Colorado Cancer Center — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Stacy Fischer, MD — University of Colorado, Denver
• Study coordinator: Mary Mancuso

Conditions Breast Cancer; Ovarian Cancer