Actively Recruiting
A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy
Led by Milton S. Hershey Medical Center · Updated on 2026-05-11
12
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, feasibility, and preliminary effectiveness of a commercially available cannabigerol (CBG) and cannabidiol (CBD) oil in adults who have chemotherapy-induced peripheral neuropathy (CIPN) after completing platinum-based chemotherapy for gastrointestinal cancers. The study builds on earlier preclinical work showing that CBG and CBD may reduce nerve pain in animal models, addressing the need for better treatments for CIPN, which current therapies often do not manage well. Participants will receive a high-CBG/CBD hemp oil extract containing small amounts of cannabichromene (CBC), taken under the tongue twice daily for 12 weeks. The dosing starts with 0.5 mL twice daily during the first week, increasing to 1 mL twice daily for the remaining 11 weeks. The treatment period is divided into three 4-week cycles, with weekly remote safety phone calls and follow-up calls one month after treatment ends to monitor safety and adherence. Throughout the study, participants will complete symptom assessments, physical and mental health evaluations, and provide blood samples to measure cannabinoid levels. Researchers will monitor safety, tolerability, treatment adherence, changes in neuropathy symptoms, physical and mental function, and cannabinoid blood levels over the 12-week treatment period. The study aims to learn if this oil is safe, feasible to use, and helpful for managing CIPN symptoms.
CONDITIONS
Brief Title
CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years or older
- Have grade 1 or greater chemotherapy-induced peripheral neuropathy symptoms lasting more than 2 weeks
- Completed platinum-based chemotherapy for certain gastrointestinal cancers within the past 2 years
- Have stopped any current treatments for peripheral neuropathy at least 2 weeks before enrollment
- Women of childbearing potential must have a negative pregnancy test
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for 1 month after
- Patients from Penn State Health
You will not qualify if you...
- Under 21 years of age
- History of neuropathy before chemotherapy
- Pregnant or nursing women
- Uncontrolled hypertension or low blood pressure
- History of stroke or heart attack
- Use of investigational drugs within 30 days or participation in another interventional study
- Liver function tests elevated more than 3 times the normal limit
- Suicidal thoughts or uncontrolled depression within the past year
- Sensitivity to CBG/CBD hemp extract or coconut oil
- Receiving active systemic anti-cancer treatments
- Use of certain medications that interact with cannabinoids or affect liver enzyme levels
- Use of other known liver-toxic drugs unless approved by study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants will administer sublingual CBG/CBD oil twice daily over a 12-week period divided into three 4-week cycles. The first week involves a lower dose, followed by a higher dose for the remaining 11 weeks. Weekly remote safety phone calls will be conducted to monitor safety and tolerability.
Weekly remote safety phone calls
Duration - Approximately 4 weeks
Participants will receive follow-up phone calls approximately one month after the last dose to monitor safety and ongoing effects.
1 follow-up phone call
Trial Site Locations
Total: 1 location
1
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
C
Crystal Sowers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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