NCT07167446 Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
| NCT ID | NCT07167446 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Fox Chase Cancer Center |
| Condition | Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2027-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-10-14 with a primary completion date of 2027-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Namrata Vijayvergia, MD
PRINCIPAL INVESTIGATOR
Fox Chase Cancer Center
Frequently Asked Questions
Who can join the NCT07167446 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07167446 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07167446 currently recruiting?
Yes, NCT07167446 is actively recruiting participants. Contact the research team at Namrata.Vijayvergia@fccc.edu for enrollment information.
Where is the NCT07167446 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07167446 clinical trial?
NCT07167446 is sponsored by Fox Chase Cancer Center. The principal investigator is Namrata Vijayvergia, MD at Fox Chase Cancer Center. The trial plans to enroll 30 participants.
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