M.D. Anderson Cancer Center
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.
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 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…
Given by po 25 mg
Given by po 1mg
No drug
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