Psilocybin-Assisted Psychotherapy in Patients with Advanced Cancer on Maintenance Therapy Experiencing Depression and/or Anxiety

Summary: 

Advances in systemic treatments like immunotherapy and targeted therapies have changed the way we think about cancer. A cancer diagnosis is no longer just a question of cure or death; there is a third possibility of living with cancer as a chronic disease. An increasing number of survivors are living with recurrent or metastatic cancer. As a result, the number of patients receiving what is called maintenance therapy is increasing. Maintenance therapy is administered for an undefined period of time to delay tumor progression. Intensive active surveillance and maintenance treatments can contribute to high levels of anxiety and depression as patients struggle to live with active disease, knowing that ultimately the treatment may stop working. This new and growing patient population has not been studied, and this lack of data significantly impedes our ability to address their emotional and psychological needs, which can adversely affect their quality of life, adherence to therapy, and survival. There is a need for novel and safe interventions that will allow these patients to cope while living with cancer. Antidepressants and benzodiazepines are used to treat depressed mood and anxiety in cancer patients. However, the evidence supporting their efficacy is limited and conflicting. Outcomes from recent trials using psilocybin to treat depression and anxiety in people with cancer are promising and warrant further investigation. Psilocybin exerts an effect on the serotonin receptor and has been associated with neuroplasticity, the brain’s ability to be “rewired”. However, to date this research has been done with people right at the end of life and actively going through the dying process. This phase II study will assess the safety and improvement in mental health from psilocybin treatment in non-terminally ill, actively treated patients with cancer. The treatment sessions will be conducted in the MD Anderson Integrative Medicine Center and overseen by two mental health care providers trained in the provision of psychedelic-assisted psychotherapy.

Trial Registration: ClinicalTrials.gov Identifier: NCT06200155