Cannabidiol (CBD) to prevent nerve damage from oxaliplatin chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label pilot with 30 patients (2:1 randomization) comparing hemp-derived CBD plus standard oxaliplatin-based chemotherapy versus standard therapy alone. Participants in the CBD arm will titrate to and generally receive 150 mg orally twice daily starting the day before each oxaliplatin dose and continuing for seven days after each cycle, with dose reductions allowed for toxicity. Neuropathy will be measured by physician-graded CTCAE v5 and patient-reported FACT-GOG NTx-13, and safety monitoring includes labs, neurologic exams, and the C-SSRS psychiatric screen. Exploratory biomarkers include circulating IL-6, TNF-α and neuropathy-associated microRNAs (miR-155, miR-146a).

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).
2. Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.
3. ECOG PS 0-2
4. No prior platinum exposure
5. No evidence of ongoing neuropathy of any grade at the time of enrollment
6. Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:

   1. Total Bilirubin: less than and/or equal to 1.5 X ULN
   2. AST(SGOT)/ALT(SGPT): less than and/or equal to 3 X ULN (5 X ULN in patients with liver metastases
7. Ability to understand and willingness to sign a written informed consent and HIPAA consent document.

   Exclusion Criteria:
8. Family history of genetic/familial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to affect cognition, Parkinson's disease, or multiple sclerosis.
9. Routine use of recreational marijuana products (defined as \> 4 times per month) or illicit drug use per self-reported history within the last 90 days. If using medical cannabis products, it should be stopped at least 1 week prior to inclusion.
10. Known underlying liver disease (Child-Pugh B or C) or baseline elevation of total bilirubin greater than and/or equal to 1.5 x upper limit of normal based on screening laboratory values.
11. 1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.
12. Patients being treated with anti-seizure or anti-psychotic medications. Patients with a prior history of anti-seizure medication use, who have been off treatment for more than 3 months, are eligible. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) is permitted.
13. Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
14. Underlying history of epilepsy/recurrent seizure disorder or unexplained seizure within past 6 months.
15. Patients with current or lifetime diagnosis of schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)
16. Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline
17. Currently taking medications known to be contraindicated with Epidiolex -FDA-approved CBD (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
18. Women who are pregnant or breastfeeding, and individuals of any sex who are capable of reproduction and unwilling to use an effective form of birth control (e.g., condoms, diaphragm, birth control pills, or IUD).
19. Patients may not be receiving any other investigational agents.

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Namrata Vijayvergia, MD — Fox Chase Cancer Center
• Study coordinator: Namrata Vijayvergia, MD
• Email: Namrata.Vijayvergia@fccc.edu
• Phone: 2152141676

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.