NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objective 1\. To assess the efficacy of psilocybin in the prevention or mitigation of chemotherapy-induced peripheral neuropathy (CIPN) in individuals undergoing adjuvant neurotoxic chemotherapy (i.e., taxanes, platinum-based compounds) for breast, colorectal, and head \& neck cancers. The primary endpoint is the proportion of participants with a ≥25% increase (worsening) from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale. The primary comparison is 25 mg psilocybin vs pooled control (standard of care + 1 mg subperceptual psilocybin), tested two-sided at α=0.05. If sign…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. Participants with histologically or cytologically confirmed breast, colorectal, or head and neck cancer. 2. Scheduled to receive platinum-based chemotherapy or taxanes (e.g., paclitaxel, docetaxel). 3. Age 18 years or older 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. No pre-existing peripheral neuropathy greater than Grade 1 as defined by the NCI-CTCAE v5.0. 6. No prior grade 3 AEs on current standard of care cancer treatment regimen 7. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental ex…
Interventions
- DrugPsilocybin (drug)
Given by po 25 mg
- DrugPsilocybin (drug)
Given by po 1mg
- OtherStandard of Care (SOC)
No drug
Location
- MD Anderson Cancer CenterHouston, Texas