BridgeMD
New treatment option for Chemotherapy-Induced Peripheral Neuropathy
Official title CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07016971
What this study is testing
What is CBG/CBD Oil?
CBG/CBD Oil is an investigational medicine, given as an once-daily, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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...
- Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal...
- 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...
You likely can't join 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...
- 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 treatment...
See the full eligibility 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...
- 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...
- 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...
- 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...
- Patients from Penn State Health.
- 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 treatment 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...
- 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...
- 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...
- Current use of other known hepatotoxic drugs unless the potential risk has been evaluated and deemed acceptable by the study investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.