CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

NCT07016971 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PSCI-24-119
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of CBG/CBD Oil

  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).

  Through study completion (12 weeks)

• Feasibility of Treatment with CBG/CBD Oil

  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.

  Week 4 (End of Cycle 1)

Secondary Outcomes (7)

• Changes in CIPN Symptoms

  Baseline (Cycle 1 Day 1, Week 0), Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose). Each cycle is 28 days.

• Changes in Physical Function

  Baseline (Cycle 1 Day 1, Week 0), Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose). Each cycle is 28 days.

• Changes in Mental Health Scores

  Baseline (Cycle 1 Day 1, Week 0), Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose). Each treatment cycle is 28 days.

• Pharmacological Tolerance to CBG/CBD Oil

  Baseline (Cycle 1 Day 1, Week 0), Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose). Each treatment cycle is 28 days.

• Changes in Circulating Cannabinoids and CBD Metabolites

  At the end of Cycle 2 (Week 8); each cycle is 28 days.

Study Arms (1)

CBG/CBD Oil Treatment Arm

EXPERIMENTAL

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.

Drug: CBG/CBD Oil

Interventions

CBG/CBD Oil 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.

CBG/CBD Oil Treatment Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

RECRUITING

Study Officials

• Nelson Yee, MD

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Sowers

CONTACT

7175315471; psci-cto@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants receive the same intervention.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 12, 2025
• Study Start: April 3, 2026
• Primary Completion (Estimated): April 3, 2029
• Study Completion (Estimated): July 3, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)