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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CBG/CBD Oil
DrugParticipants 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CBG/CBD Oil Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Through study completion (12 weeks)2
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.
Time frame
Week 4 (End of Cycle 1)Secondary outcomes
1
Changes in CIPN Symptoms
The PNQ grades the severity of chemotherapy-induced peripheral neuropathy (CIPN) symptoms on a scale from 0 to 4, where: 0: No neuropathy. 1. Mild neuropathy; does not interfere with daily activities. 2. Moderate neuropathy; some interference with daily activities. 3. Severe neuropathy; significant interference with daily activities. 4. Disabling neuropathy; prevents daily activities. Minimum value: 0 (no neuropathy). Maximum value: 4 (disabling neuropathy). Interpretation: Higher scores indicate worse outcomes (more severe neuropathy symptoms). Symptoms will be assessed for changes in sensory and motor disturbances and their impact on daily activities.
Time frame
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.2
Changes in Physical Function
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a. This scale assesses the impact of muscle weakness associated with chemotherapy-induced peripheral neuropathy (CIPN) on daily activities. The PROMIS Physical Function Short Form 20a consists of 20 items, with responses scored from 1 to 5: 1: Unable to do or severe limitation. 5: No difficulty or limitation. Minimum value: 20 (indicating severe limitation across all items). Maximum value: 100 (indicating no limitation across all items). Interpretation: Higher scores indicate better outcomes (better physical function). Physical function will be assessed by comparing baseline scores to those collected at the end of each cycle.
Time frame
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.3
Changes in Mental Health Scores
Assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety Short Form 8a and PROMIS Cognitive Function - Short Form 8a. Anxiety Short Form 8a: 8 items, scored 1 (never) to 5 (always); T-scores range from \~37.1 (minimal anxiety) to \~83.1 (severe anxiety). Higher T-scores indicate worse outcomes. Cognitive Function Short Form 8a: 8 items, scored 1 (poor function) to 5 (good function); T-scores range from \~25.0 (poor) to \~75.0 (excellent). Higher T-scores indicate better outcomes. Changes in T-scores from baseline to end of each cycle.
Time frame
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.4
Pharmacological Tolerance to CBG/CBD Oil
Measured by changes in Patient Neurotoxicity Questionnaire (PNQ) scores, assessing the decrease in the effectiveness of CBG/CBD oil treatment for chemotherapy-induced peripheral neuropathy (CIPN) symptoms. The PNQ grades the severity of sensory and motor disturbances on a scale from 0 to 4, where: 0: No neuropathy. 1. Mild neuropathy; does not interfere with daily activities. 2. Moderate neuropathy; some interference with daily activities. 3. Severe neuropathy; significant interference with daily activities. 4. Disabling neuropathy; prevents daily activities. Minimum value: 0 (no neuropathy). Maximum value: 4 (disabling neuropathy). Interpretation: Higher scores indicate worse outcomes (more severe neuropathy symptoms, suggesting decreased treatment effectiveness). Changes in PNQ scores will be evaluated by comparing baseline scores to those collected at the end of each cycle to assess potential pharmacological tolerance.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov