CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

This study is looking at whether a commercially available CBG/CBD oil can help adults with chemotherapy-induced peripheral neuropathy (CIPN), which is nerve damage causing pain, numbness, or weakness after chemotherapy. Specifically, it's for people who have finished platinum-based chemotherapy for gastrointestinal cancers and still have CIPN symptoms. The main goals are to see if the CBG/CBD oil is safe and easy to use over 12 weeks, and if it helps reduce CIPN symptoms like pain or numbness. This is a small study, planning to include 12 participants. The study is currently unclear on its recruitment status.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved: Participants will take the CBG/CBD oil twice daily for 12 weeks. The dose will be 0.5 mL twice daily for the first week, then 1 mL twice daily for the remaining 11 weeks.
Compensation: Not stated in the trial record.
Follow-up: Safety and tolerability will be measured through study completion (12 weeks). Feasibility will be measured at Week 4.

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CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

Recruiting

PHASE1Ages 21+InterventionalTreatment

Milton S. Hershey Medical Center

~12 participants

Updated 2026-05-11 on ClinicalTrials.gov

What's tested:CBG/CBD Oil

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Safety and Tolerability of CBG/CBD Oil

Measured over Through study completion (12 weeks)

+1 more outcome measured

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Where it's being run

1 sites across 1 states

Pennsylvania1

Study leadership

Nelson Yee, MD · PRINCIPAL_INVESTIGATOR · Penn State Cancer Institute

Who to contact

Crystal Sowers

[email protected]

7175315471

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Safety and Tolerability of CBG/CBD OilThrough study completion (12 weeks)
Evaluated by the incidence and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The NCI CTCAE v5.0 grades adverse events on a scale from 1 to 5, where: Grade 1: Mild; asymptomatic or mild symptoms. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Minimum value: Grade 1 (mild). Maximum value: Grade 5 (death). Interpretation: Higher grades indicate worse outcomes (more severe adverse events). Focus will be on toxicities of grade 2 or higher throughout the 12-week treatment period (Cycles 1-3).
Feasibility of Treatment with CBG/CBD OilWeek 4 (End of Cycle 1)
Defined as the percentage of participants who complete Cycle 1 (Weeks 1-4) of study participation, including all required visits, assessments, and adherence to CBG/CBD oil dosing.

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