CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy

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.