Actively Recruiting
Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study
Led by Fox Chase Cancer Center · Updated on 2025-10-22
30
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the use of hemp-derived cannabidiol (CBD) supplementation to prevent neuropathy caused by oxaliplatin chemotherapy in patients with metastatic colorectal cancer. This pilot, prospective, randomized study aims to assess the feasibility and acceptability of adding CBD to standard oxaliplatin-based chemotherapy. The study excludes patients with pre-existing neuropathy, previous oxaliplatin exposure, or current cannabinoid use. Participants will be randomly assigned in a 2:1 ratio to receive either CBD capsules plus standard chemotherapy or standard chemotherapy alone. Those in the CBD group will take 150 mg of oral CBD twice daily, starting the day before oxaliplatin treatment and continuing for seven days after each chemotherapy cycle, with dose adjustments allowed for side effects. Chemotherapy will follow standard 2- to 3-week cycles for up to 6 months. Compliance will be tracked through pill counts and patient reports. Throughout the study, neuropathy symptoms will be monitored by doctors and patient questionnaires. Safety assessments include lab tests, neurological exams, and psychiatric evaluations. Researchers will also explore inflammatory markers and microRNAs related to neuropathy. The main outcomes focus on participant adherence to CBD and its acceptability over 12 weeks. The total study enrollment is 30 patients, with follow-up continuing through chemotherapy and shortly after treatment completion.
CONDITIONS
Brief 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 for oxaliplatin-based chemotherapy for at least 3 months
- May have received one cycle of oxaliplatin-based chemotherapy before enrollment
- ECOG performance status of 0 to 2
- No prior exposure to platinum chemotherapy
- No existing neuropathy of any grade at enrollment
- Adequate marrow and organ function, including total bilirubin ≤1.5 times upper limit of normal and AST/ALT ≤3 times upper limit of normal (or ≤5 times if liver metastases present)
- Able and willing to provide written informed consent and HIPAA authorization
You will not qualify if you...
- Family history of genetic or familial neuropathy or personal ongoing neuropathy or nervous system diseases affecting cognition, Parkinson's disease, or multiple sclerosis
- Routine recreational marijuana use more than 4 times per month or illicit drug use in the past 90 days; medical cannabis use must be stopped one week before enrollment
- Known liver disease (Child-Pugh B or C) or elevated 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 or prior anti-seizure use off treatment for over 3 months
- Use of strong inducers of CYP3A4 or CYP2C19 enzymes
- History of epilepsy, recurrent seizures, or unexplained seizures within 6 months
- Diagnosis of schizophrenia spectrum, psychotic, bipolar I or II, cluster B personality, or eating disorders
- Recent major depression with suicidal thoughts
- Use of medications contraindicated with FDA-approved CBD (Epidiolex)
- Pregnancy, breastfeeding, or unwillingness to use effective birth control
- Participation in other investigational drug studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive oxaliplatin-based chemotherapy every 2 to 3 weeks for up to 6 months. Those in the intervention arm also take oral hemp-derived CBD capsules starting the day before each chemotherapy cycle and continuing for 7 days after each cycle, with dose adjustments as needed.
Chemotherapy visits every 2 to 3 weeks with additional daily oral CBD during treatment cycles for the intervention arm
Duration - Up to 4 weeks
Participants are monitored for up to 4 weeks after completing oxaliplatin chemotherapy to assess neuropathy symptoms, adverse events, and safety.
Approximately 1 to 2 post-treatment visits
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
N
Namrata Vijayvergia, MD
H
Henkel Valentine, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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