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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT07167446
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer (CRC)
  • Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
  • Peripheral Neuropathy Due to Chemotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol (CBD) — DRUG
    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.
  • oxaliplatin-based chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Oct 2025
Primary completion
Sep 5, 2027
Completion
Sep 7, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cannabidiol (CBD)
    Participants receive hemp-derived cannabidiol (CBD) capsules in addition to standard oxaliplatin-based chemotherapy.
  • Active Comparator: Standard of Care
    Participants receive standard oxaliplatin-based chemotherapy without CBD supplementation

Primary Outcome Measure

Proportion 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Namrata Vijayvergia
[email protected]
215-214-1676

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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