NCT07016971

CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed 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 symptoms. The study intervention uses a high-CBG/CBD hemp oil extract that is marketed as a dietary supplement and contains a verified profile of cannabinoids and terpenes. The formulation also includes small amounts of cannabichromene (CBC), which may contribute to analgesic effects via the "entourage effect." Subjects will administer 0.5 mL sublingually twice daily during the first week, followed by 1 mL sublingually twice daily for the remaining 11 weeks of the 12-week treatment period. The treatment period is divided into three 4-week cycles to structure visit scheduling and assessments. The study will collect data on symptom changes, physical function, mental health, tolerability, and cannabinoid levels over time. Primary objectives include evaluating the safety and tolerability of CBG/CBD oil and the feasibility of its use in this patient population. Secondary objectives include measuring changes in CIPN symptoms, physical and mental function, adherence, pharmacological tolerance, and circulating cannabinoid/metabolite levels. The study addresses an urgent need for effective treatments for CIPN, as current therapies (e.g., duloxetine, gabapentin, NSAIDs) are often inadequate and poorly tolerated. By assessing a hemp extract rather than a purified compound, this study also explores the broader applicability and real-world relevance of cannabinoid-based supplements for supportive cancer care.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	CBG/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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2029-07-01
• First posted: 2025-06-12
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study