A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy
Milton S. Hershey Medical Center
Summary
The goal of this clinical trial is to learn if a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil is safe, feasible to use, and can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adults who have completed platinum-based chemotherapy for gastrointestinal cancers. The main questions it aims to answer are: Is CBG/CBD oil safe and well-tolerated over a 12-week treatment period? Can participants with CIPN use CBG/CBD oil consistently as part of their care? Does CBG/CBD oil help reduce pain, numbness, or other symptoms of CIPN? Participants will: Take CBG/CBD oil under the tongue (sublingually) twice daily for 12 weeks Complete regular symptom assessments and functional tests during study visits Provide blood samples for cannabinoid and metabolite level testing
Description
This pilot clinical trial is designed to evaluate the safety, feasibility, and preliminary efficacy of a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have completed platinum-based chemotherapy for gastrointestinal malignancies. The study is based on preclinical findings from Dr. Wesley Raup-Konsavage's laboratory, which showed that CBG and CBD reduced neuropathic pain in animal models of CIPN. This clinical trial seeks to translate these findings into a patient population with persistent CIPN…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 21 years or older. * Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5. * Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years. * Patients currently taking any treatment for CIPN must disconti…
Interventions
- DrugCBG/CBD Oil
Participants will receive a commercially available high CBG/CBD hemp extract oil that also contains small amounts of cannabichromene (CBC). The product is formulated as a sublingual oil and administered twice daily. Participants will take 0.5 mL of the oil sublingually twice daily during the first week, followed by 1 mL sublingually twice daily for the remaining 11 weeks. The oil has a defined and independently verified cannabinoid and terpene profile and is marketed as a dietary supplement.
Location
- Penn State Cancer InstituteHershey, Pennsylvania