NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.
Eligibility criteria
Qualifiers
Participants with histologically or cytologically confirmed breast, colorectal, or head and neck cancer.
Scheduled to receive platinum-based chemotherapy or taxanes (e.g., paclitaxel, docetaxel).
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Disqualifiers
Malignancy treated with curative intent and no active disease for ≥ 5 years before the first dose of study drug, with low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
Trial design
Treatments tested in this trial
- Psilocybin (drug)
- Psilocybin (drug)
- Standard of Care (SOC)
Treatment groups
83 Participants
are divided into 3 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Usona Institute
Collaborator
Source ClinicalTrials.gov