RecruitingEarly Phase 1NCT07167446

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

Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study


Sponsor

Fox Chase Cancer Center

Enrollment

30 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether cannabidiol (CBD) — a non-psychoactive compound from cannabis — can prevent or reduce nerve damage (neuropathy) caused by oxaliplatin, a common chemotherapy drug used in colon cancer treatment. Oxaliplatin-induced neuropathy causes numbness, tingling, and pain in the hands and feet, and there is currently no reliable preventive treatment. **You may be eligible if...** - You have metastatic or locally advanced colorectal cancer that cannot be removed surgically - You are planned to receive oxaliplatin-based chemotherapy for at least 3 months - You have no prior nerve damage (neuropathy) - You have not previously been treated with platinum-based chemotherapy - Your liver and overall organ function meet required levels **You may NOT be eligible if...** - You already have nerve damage of any kind - You have had prior oxaliplatin or other platinum chemotherapy - You have significant liver dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCannabidiol (CBD)

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.

DRUGoxaliplatin-based chemotherapy

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.


Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT07167446


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