Actively Recruiting
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Led by Fox Chase Cancer Center · Updated on 2025-10-22
30
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) supplementation to prevent oxaliplatin-induced peripheral neuropathy (OIPN) in patients receiving oxaliplatin-based chemotherapy for colorectal cancer (CRC). Participants will be randomized to receive either CBD capsules in addition to standard therapy or standard therapy alone.
CONDITIONS
Official Title
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic, locally advanced unresectable colorectal cancer planned to receive oxaliplatin-based chemotherapy for at least 3 months
- Allowed to have received one cycle of oxaliplatin chemotherapy before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- No prior platinum chemotherapy exposure
- No ongoing neuropathy of any grade at enrollment
- Liver function with total bilirubin ≤ 1.5 times upper limit of normal and AST/ALT ≤ 3 times upper limit (≤ 5 times if liver metastases present)
- Ability to understand and willing to sign informed consent and HIPAA forms
You will not qualify if you...
- Family history of genetic or familial neuropathy or personal history of neuropathy or nervous system diseases affecting cognition, Parkinson's disease, or multiple sclerosis
- Routine recreational marijuana use (>4 times/month) or illicit drug use within last 90 days; medical cannabis must be stopped at least 1 week before enrollment
- Known liver disease (Child-Pugh B or C) or total bilirubin ≥ 1.5 times upper limit of normal
- Untreated brain metastases or treated brain metastases requiring anti-seizure medications
- Current treatment with anti-seizure or anti-psychotic medications (except SSRIs); prior anti-seizure medication use allowed if stopped >3 months ago
- Use of strong CYP3A4 or CYP2C19 inducers
- History of epilepsy, recurrent seizures, or unexplained seizure within past 6 months
- Diagnosis of schizophrenia spectrum, psychotic, bipolar I/II, cluster B personality, or eating disorders
- Recent major depression with suicidal thoughts per investigator assessment
- Current use of medications contraindicated with FDA-approved CBD (Epidiolex)
- Pregnant or breastfeeding women, or individuals unwilling to use effective birth control
- Receiving other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
N
Namrata Vijayvergia, MD
CONTACT
H
Henkel Valentine, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here