Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study
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.
• Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).
• Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.
• ECOG PS 0-2
• No prior platinum exposure
• No evidence of ongoing neuropathy of any grade at the time of enrollment
• Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:
‣ Total Bilirubin: less than and/or equal to 1.5 X ULN
⁃ AST(SGOT)/ALT(SGPT): less than and/or equal to 3 X ULN (5 X ULN in patients with liver metastases
• Ability to understand and willingness to sign a written informed consent and HIPAA consent document.