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
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.
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.
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.
1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.
Parallel
Cannabidiol (CBD)
DrugOral hemp-derived CBD capsules, 150 mg twice daily (with titration in Cycle 1; dose reductions permitted for tolerability). Administered starting the day before oxaliplatin infusion and continued for 7 days after each chemotherapy cycle.
oxaliplatin-based chemotherapy
DrugStandard of care oxaliplatin-based regimens per NCCN guidelines (e.g., FOLFOX or CAPEOX), administered in 2-3 week cycles for a maximum of 6 months.
Proportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs.
Acceptability of CBD supplementation as measured by the Feasibility of Intervention Measure (FIM)
5-point Likert scale, each item is scored 1-5. Higher scores = higher acceptability and feasibility of implementing the intervention
Incidence of physician-reported chemotherapy-induced peripheral neuropathy (CIPN), defined as Grade ≥2 by CTCAE v5.0.
Change from baseline in patient-reported neuropathy symptoms using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT-GOG NTx-13) scale
Each item is scored on a 5-point Likert scale (0 = Not at all to 4 = Very much). Total scores range from 0 to 52, with higher scores indicating more severe neuropathy symptoms
Incidence and profile of treatment-emergent adverse events (TEAEs), as classified by CTCAE v5.0
Click on the lead sponsor to view all of their trials.
Fox Chase Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
