CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorMilton S. Hershey Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- CBG/CBD Oil
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov