Ovarian Cancer Clinical Trial

A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Summary

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question[s] it aims to answer [is/are]:

Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life?

Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

View Eligibility Criteria

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:

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

Risk for hypertensive crisis defined as:

Screening, Baseline, Medication session (predose) blood pressure >140/90 mmHg

Significant central nervous system (CNS) pathology

Examples include:

Primary or secondary cerebral neoplasm
Epilepsy
History of stroke
Cerebral aneurysm
Dementia
Delirium

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

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

High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:

Agitation
Violent behavior

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

Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:

Any use in the last 12 months
>25 lifetime uses

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
History of hallucinogen persisting perception disorder (HPPD)
Pregnancy/lactation

Cognitive impairment as defined by:

• Montreal Cognitive Assessment Test (MoCA) < 23

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
Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), and Phencyclidine (PCP).
Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
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.
Have an allergy or intolerance to any of the materials contained in the drug product
Non-English speaking individual
Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT06430541

Recruitment Status:

Not yet recruiting

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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Outpatient CTRC
Aurora Colorado, 80045, United States More Info
Stacy Fischer, MD
Principal Investigator
University of Colorado Cancer Center
Aurora Colorado, 80045, United States More Info
Stacy Fischer, MD
Contact
303-724-6353
[email protected]
Stacy Fischer, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT06430541

Recruitment Status:

Not yet recruiting

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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