CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT07016971

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-05-01

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBG/CBD Oil

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

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 (To be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).
• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wesley Raup-Konsavage

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelson Yee, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Cancer Institute

Locations

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Countries

United States

Central Contacts

Crystal Sowers

Role: CONTACT

psci-cto@pennstatehealth.psu.edu

7175315471

Other Identifiers

PSCI-24-119

Identifier Type: -

Identifier Source: org_study_id