A Study to See if Cannabidiol CBD Can Protect Against Nerve Damage Caused by Oxaliplatin Chemotherapy in Metastatic Colorectal Cancer Patients

What this Trial Is About

Researchers are evaluating the use of hemp-derived cannabidiol CBD supplementation to prevent neuropathy caused by oxaliplatin chemotherapy in patients with metastatic colorectal cancer. This pilot, prospective, randomized study aims to assess the feasibility and acceptability of adding CBD to standard oxaliplatin-based chemotherapy. The study excludes patients with pre-existing neuropathy, previous oxaliplatin exposure, or current cannabinoid use. Participants will be randomly assigned in a 21 ratio to receive either CBD capsules plus standard chemotherapy or standard chemotherapy alone. Those in the CBD group will take 150 mg of oral CBD twice daily, starting the day before oxaliplatin treatment and continuing for seven days after each chemotherapy cycle, with dose adjustments allowed for side effects. Chemotherapy will follow standard 2- to 3-week cycles for up to 6 months. Compliance will be tracked through pill counts and patient reports. Throughout the study, neuropathy symptoms will be monitored by doctors and patient questionnaires. Safety assessments include lab tests, neurological exams, and psychiatric evaluations. Researchers will also explore inflammatory markers and microRNAs related to neuropathy. The main outcomes focus on participant adherence to CBD and its acceptability over 12 weeks. The total study enrollment is 30 patients, with follow-up continuing through chemotherapy and shortly after treatment completion.

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