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

This will try a CBG/CBD oil to see if it safely reduces pain, numbness, or other nerve symptoms in adults who developed peripheral neuropathy after platinum-based chemotherapy for gastrointestinal cancers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT07016971 on ClinicalTrials.gov

What this trial studies

This Phase 1 pilot gives adults with persistent CIPN a commercially available high-CBG/CBD hemp oil sublingually for 12 weeks to test safety, tolerability, and preliminary symptom effects. Dosing starts at 0.5 mL twice daily for one week, then increases to 1 mL twice daily for the remaining 11 weeks, with the treatment period organized into three four-week cycles. Participants complete regular symptom and functional assessments and provide blood samples for cannabinoid and metabolite levels at study visits. The trial is motivated by preclinical animal data showing reduced neuropathic pain with CBG and CBD and seeks to translate those findings into humans.

Who should consider this trial

Good fit: Adults aged 21 or older with grade 1 or greater CIPN after platinum-based chemotherapy for specified gastrointestinal cancers within the past two years, who can stop other CIPN treatments before enrollment and, if of childbearing potential, have a negative pregnancy test, are ideal candidates.

Not a fit: People with neuropathy not related to platinum chemotherapy, those who cannot discontinue current CIPN treatments, pregnant people or those unwilling to attend in-person visits or provide blood samples may not receive benefit from participation.

Why it matters

Potential benefit: If successful, this could offer a safe, at-home oral option to reduce CIPN pain and improve function for survivors of gastrointestinal cancers.

How similar studies have performed: Preclinical animal studies reported that CBG and CBD reduced neuropathic pain, but clinical evidence for CBG/CBD in human CIPN is limited and this pilot is an early, novel test.

Eligibility criteria

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 discontinue such treatments at least 2 weeks prior to enrollment.
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (A pregnancy teste will be performed during screening (up to 28 days before treatment and repeated within 7 days prior to study drug initiation to confirm baseline status and minimize risk of unrecognized pregnancy).
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
* Patients from Penn State Health.

Exclusion Criteria:

* Patients under the age of 21 years.
* Patients with a history of preexisting neuropathy prior to chemotherapy.
* Pregnant and nursing women.
* Patients with hypertension that, in the investigator's judgement, is uncontrolled despite the use of anti-hypertensives, or with hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg).
* History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction).
* Patients who have used an investigational drug within 30 days prior to the screening visit or are currently participating in another interventional investigational study.
* Patients who have liver function tests AST/ALT \> 3 times above the upper limits of normal (ULN) in the past year.
* Patients who have suicidal ideation or uncontrolled depression within the past year.
* Patients with known sensitivity to any components of CBG/CBD hemp extract.
* Patients with known sensitivity to coconut oil.
* Patients currently receiving active systemic anti-cancer therapies, including but not limited to chemotherapy, immunotherapy, targeted therapy (e.g., tyrosine kinase inhibitors, anti-HER2 therapy), or any other ongoing systemic treatment intended to control or reduce tumor burden.
* Current use of moderate or strong inhibitors or inducers of CYP3A4 or CYP2C19.
* Current use of sensitive CYP2C19 substrates with narrow therapeutic indices (e.g., diazepam, clobazam), unless the subject's primary physician agrees to adjust the dose and provide close therapeutic monitoring.
* Current use of valproate or other medications known to significantly increase the risk of liver enzyme elevations when co-administered with cannabidiol.
* Current use of medications that are primarily metabolized by CYP1A2 (e.g., theophylline) or CYP2B6 (e.g., bupropion, efavirenz) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator. Occasional or dietary caffeine intake is permitted.
* Current use of medications that are substrates of UGT1A9 (e.g., diflunisal, propofol, fenofibrate), UGT2B7 (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8, or CYP2C9 (e.g., phenytoin) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator.
* Current use of other known hepatotoxic drugs unless the potential risk has been evaluated and deemed acceptable by the study investigator.

Where this trial is running

Hershey, Pennsylvania

• Penn State Cancer Institute — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Nelson Yee, MD — Penn State Cancer Institute
• Study coordinator: Crystal Sowers

Conditions Chemotherapy-Induced Peripheral Neuropathy