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 colorectal cancer (mCRC) scheduled to receive at least 3 months of oxaliplatin-based chemotherapy will be enrolled on this prospective, randomized, open-label pilot study. A total of 30 patients will be randomized 2:1, with 20 patients assigned to the CBD supplementation arm and 10 patients assigned to the standard of care arm. Patients with pre-existing neuropathy, prior oxaliplatin exposure, or active cannabinoid use will be excluded. Patients in the intervention arm will receive hemp-derived CBD capsules at a dose of 150 mg orally twice daily (following a titration during Cycle 1) starting the day before oxaliplatin and continuing through 7 days after each chemotherapy cycle. Standard oxaliplatin-based chemotherapy will be administered every 2-3 weeks per NCCN guidelines. Compliance will be monitored through pill counts, patient reporting, and scheduled check-ins. Dose adjustments to 100 mg or 50 mg twice daily will be permitted for treatment-related adverse events at investigator discretion. Neuropathy will be assessed using both physician grading (CTCAE v5) and patient-reported outcomes (FACT-GOG NTx-13). Safety monitoring will include laboratory tests, neurological and physical examinations, and psychiatric evaluation with the Columbia Suicide Severity Rating Scale (C-SSRS). Exploratory analyses will measure circulating inflammatory cytokines (IL-6, TNF-α) and neuropathy-associated microRNAs (miR-155, miR-146a). A total of 30 patients (20 intervention, 10 control) will be enrolled at Fox Chase Cancer Center over a 2-year period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Oral 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.
Standard 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.
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGProportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs.
Time frame: Baseline through Week 12 of treatment
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
Time frame: Baseline through Week 12 of treatment
Incidence of physician-reported chemotherapy-induced peripheral neuropathy (CIPN), defined as Grade ≥2 by CTCAE v5.0.
Time frame: From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)
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
Time frame: From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)
Incidence and profile of treatment-emergent adverse events (TEAEs), as classified by CTCAE v5.0
Time frame: From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)
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