Recruiting
Phase 1

CBG & CBD

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT07016971

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

CBG/CBD Oil

Study Details

Brief 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

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Study ID

NCT07016971

Start date

Apr 3, 2026

Status verified date

May, 2026

Completion date

Jul 3, 2029

Anticipated

Primary completion date

Apr 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBG/CBD Oil Treatment Arm

This is a single-arm, open-label study in which all participants will receive the intervention of CBG/CBD oil treatment. Participants will be administered sublingual CBG/CBD oil for 12 weeks. The initial dose will be 0.5 mL (17 mg of cannabinoids) twice daily for the first week, followed by 1 mL (33 mg of cannabinoids) twice daily for the remaining 11 weeks. The treatment period is divided into three 4-week cycles. Weekly remote safety phone calls will be conducted, and follow-up phone calls will take place one month after the last dose to monitor safety. The primary goals are to evaluate the safety, tolerability, and feasibility of the CBG/CBD oil, while secondary goals include assessing changes in CIPN symptoms, physical function, mental health, pharmacological tolerance, and adherence to the treatment.

Interventions

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.

Primary outcome measure

  • Safety and Tolerability of CBG/CBD Oil [ Time Frame: Through study completion (12 weeks) ]
  • Feasibility of Treatment with CBG/CBD Oil [ Time Frame: Week 4 (End of Cycle 1) ]

Central Contacts and Locations

Central contacts

Crystal Sowers

7175315471psci-cto@pennstatehealth.psu.edu

Locations

Penn State Cancer Institute

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

717-531-5471PSCI-CTO@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-05-11.