NCT07016971 CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
| NCT ID | NCT07016971 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-03 |
| Primary Completion | 2029-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-04-03 with a primary completion date of 2029-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Nelson Yee, MD
PRINCIPAL INVESTIGATOR
Penn State Cancer Institute
Frequently Asked Questions
Who can join the NCT07016971 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07016971 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07016971 currently recruiting?
Yes, NCT07016971 is actively recruiting participants. Contact the research team at psci-cto@pennstatehealth.psu.edu for enrollment information.
Where is the NCT07016971 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT07016971 clinical trial?
NCT07016971 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Nelson Yee, MD at Penn State Cancer Institute. The trial plans to enroll 12 participants.