NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07227909
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Neuropathy
  • Psilocybin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (drug) — DRUG
    Given by po 25 mg
  • Psilocybin (drug) — DRUG
    Given by po 1mg
  • Standard of Care (SOC) — OTHER
    No drug

Study Details

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.

Key Dates

Start date
Nov 4, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
83 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm A
    Two supervised oral doses 1 week apart prior to chemotherapy cycle 1 (Day 7 and Day 14), followed by two monthly supervised doses prior to chemotherapy cycles 2 and 3 (Day 42 and Day 70); total 4 doses.
  • Experimental: Arm B
    Subperceptual dosing every other day for 2 weeks during the pre-chemotherapy run-in (mailed 7×1 mg capsules in tamperevident packaging) prior to the first three cycles as above (21 total doses)
  • Experimental: Arm C
    Standard of Care: Chemotherapy and supportive care per institutional guidelines; no study drug.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

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By research site
MD Anderson Cancer Center· Houston, TX

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