Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Trial Parameters
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 af