Chemotherapy-Induced Peripheral NeuropathyPhase 1NCT07016971
CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
A Phase 1 study testing CBG/CBD Oil in people with Chemotherapy-Induced Peripheral Neuropathy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- CBG/CBD Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2026to 3 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
717-531-5471, PSCI-CTO@pennstatehealth.psu.edu
About this study
Official title: A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy
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?
Read more
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
Read the detailed description
This pilot clinical trial is designed to evaluate the safety, feasibility, and preliminary efficacy of a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have completed platinum-based chemotherapy for gastrointestinal malignancies. The study is based on preclinical findings from Dr. Wesley Raup-Konsavage's laboratory, which showed that CBG and CBD reduced neuropathic pain in animal models of CIPN. This clinical trial seeks to translate these findings into a patient population with persistent CIPN symptoms.
The study intervention uses a high-CBG/CBD hemp oil extract that is marketed as a dietary supplement and contains a verified profile of cannabinoids and terpenes. The formulation also includes small amounts of cannabichromene (CBC), which may contribute to analgesic effects via the "entourage effect." Subjects will administer 0.5 mL sublingually twice daily during the first week, followed by 1 mL sublingually twice daily for the remaining 11 weeks of the 12-week treatment period.
The treatment period is divided into three 4-week cycles to structure visit scheduling and assessments. The study will collect data on symptom changes, physical function, mental health, tolerability, and cannabinoid levels over time.
Primary objectives include evaluating the safety and tolerability of CBG/CBD oil and the feasibility of its use in this patient population. Secondary objectives include measuring changes in CIPN symptoms, physical and mental function, adherence, pharmacological tolerance, and circulating cannabinoid/metabolite levels.
The study addresses an urgent need for effective treatments for CIPN, as current therapies (e.g., duloxetine, gabapentin, NSAIDs) are often inadequate and poorly tolerated. By assessing a hemp extract rather than a purified compound, this study also explores the broader applicability and real-world relevance of cannabinoid-based supplements for supportive cancer care.
- Being tested
- CBG/CBD Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBG/CBD OilDrug
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| CBG/CBD Oil Treatment Arm | Experimental | This is a single-arm, open-label study in which all participants will receive the intervention of CBG/CBD oil treatment. Participants will be administered sublingual CBG/CBD oil for 12 weeks. The initial dose will be 0.5 mL (17 mg of cannabinoids) twice daily for the first week, followed by 1 mL (33 mg of cannabinoids) twice daily for the remaining 11 weeks. The treatment period is divided into three 4-week cycles. Weekly remote safety phone calls will be conducted, and follow-up phone calls will take place one month after the last dose to monitor safety. The primary goals are to evaluate the safety, tolerability, and feasibility of the CBG/CBD oil, while secondary goals include assessing changes in CIPN symptoms, physical function, mental health, pharmacological tolerance, and adherence to the treatment. Receives: Drug: CBG/CBD Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion (12 weeks)
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.
Measured: Week 4 (End of Cycle 1)
Secondary outcomes (7)
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.
- Mild neuropathy; does not interfere with daily activities.
- Moderate neuropathy; some interference with daily activities.
- Severe neuropathy; significant interference with daily activities.
- 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
- Mild neuropathy; does not interfere with daily activities.
- Moderate neuropathy; some interference with daily activities.
- Severe neuropathy; significant interference with daily activities.
- 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.
Measured: 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.
Changes in Circulating Cannabinoids and CBD Metabolites
Measured as the difference in plasma concentrations of cannabinoids and CBD metabolites (e.g., CBG, CBD, and their metabolites) from baseline to the end of Cycle 2. Plasma levels will be quantified using validated analytical methods (liquid chromatography-mass spectrometry).
Measured: At the end of Cycle 2 (Week 8); each cycle is 28 days.
Adherence to CBG/CBD Oil Treatment
Defined as the proportion of prescribed CBG/CBD oil doses taken per cycle. Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale and patient drug diaries.
PROMIS Medication Adherence Scale: Items scored 1 (never) to 5 (always); T-scores range from ~30.0 (poor adherence) to ~70.0 (excellent adherence). Higher T-scores indicate better outcomes.
Drug Diaries: Record daily doses to calculate proportion taken. Adherence assessed by combining T-scores and diary data per cycle.
Measured: Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose), corresponding to adherence during Cycles 1-3 (each cycle is 28 days).
Change in acute sensory neuropathy symptoms and correlation with plasma cannabinoid concentrations following CBG/CBD oil administration
Acute sensory symptoms are assessed using the Patient Neurotoxicity Questionnaire sensory item (PNQ1). PNQ1 scores are analyzed in relation to plasma cannabinoid concentrations collected at corresponding timepoints.
Measured: Cycle 3 Day 1 at 1 hour, 4 hours, and 6 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start3 Apr 2026
- Primary completion3 Apr 2029 (estimated)
- Study completion3 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Raup-Konsavage, Milton S. Hershey Medical Center
- Investigators
- Nelson Yee, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016971
- Sponsor's protocol ID
- PSCI-24-119
- Status last verified
- May 2026
- First submitted
- 30 May 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07016971
- Acronym / sponsor ID
- PSCI-24-119
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 3 Apr 2029 (estimated)
- Study completion
- 3 Jul 2029 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This pilot clinical trial is designed to evaluate the safety, feasibility, and preliminary efficacy of a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have completed platinum-based chemotherapy for gastrointestinal malignancies. The study is based on preclinical findings from Dr. Wesley Raup-Konsavage's laboratory, which showed that CBG and CBD reduced neuropathic pain in animal models of CIPN. This clinical trial seeks to translate these findings into a patient population with persistent CIPN symptoms.
The study intervention uses a high-CBG/CBD hemp oil extract that is marketed as a dietary supplement and contains a verified profile of cannabinoids and terpenes. The formulation also includes small amounts of cannabichromene (CBC), which may contribute to analgesic effects via the "entourage effect." Subjects will administer 0.5 mL sublingually twice daily during the first week, followed by 1 mL sublingually twice daily for the remaining 11 weeks of the 12-week treatment period.
The treatment period is divided into three 4-week cycles to structure visit scheduling and assessments. The study will collect data on symptom changes, physical function, mental health, tolerability, and cannabinoid levels over time.
Primary objectives include evaluating the safety and tolerability of CBG/CBD oil and the feasibility of its use in this patient population. Secondary objectives include measuring changes in CIPN symptoms, physical and mental function, adherence, pharmacological tolerance, and circulating cannabinoid/metabolite levels.
The study addresses an urgent need for effective treatments for CIPN, as current therapies (e.g., duloxetine, gabapentin, NSAIDs) are often inadequate and poorly tolerated. By assessing a hemp extract rather than a purified compound, this study also explores the broader applicability and real-world relevance of cannabinoid-based supplements for supportive cancer care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| CBG/CBD Oil Treatment Arm | Experimental | Drug: CBG/CBD OilThis is a single-arm, open-label study in which all participants will receive the intervention of CBG/CBD oil treatment. Participants will be administered sublingual CBG/CBD oil for 12 weeks. The initial dose will be 0.5 mL (17 mg of cannabinoids) twice daily for the first week, followed by 1 mL (33 mg of cannabinoids) twice daily for the remaining 11 weeks. The treatment period is divided into three 4-week cycles. Weekly remote safety phone calls will be conducted, and follow-up phone calls will take place one month after the last dose to monitor safety. The primary goals are to evaluate the safety, tolerability, and feasibility of the CBG/CBD oil, while secondary goals include assessing changes in CIPN symptoms, physical function, mental health, pharmacological tolerance, and adherence to the treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBG/CBD OilParticipants 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. | Drug | CBG/CBD Oil Treatment Arm |
Primary outcome
Safety and Tolerability of CBG/CBD Oil
Time frame: Through study completion (12 weeks)
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).
Feasibility of Treatment with CBG/CBD Oil
Time frame: Week 4 (End of Cycle 1)
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.
7 secondary outcomes
Changes in CIPN Symptoms
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.
Changes in Physical Function
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.
Changes in Mental Health Scores
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.
Pharmacological Tolerance to CBG/CBD Oil
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.
Changes in Circulating Cannabinoids and CBD Metabolites
Time frame: At the end of Cycle 2 (Week 8); each cycle is 28 days.
Adherence to CBG/CBD Oil Treatment
Time frame: Cycle 2 Day 1 (Week 4), Cycle 3 Day 1 (Week 8), and End of Treatment (Week 12; approximately 4 weeks after last dose), corresponding to adherence during Cycles 1-3 (each cycle is 28 days).
Change in acute sensory neuropathy symptoms and correlation with plasma cannabinoid concentrations following CBG/CBD oil administration
Time frame: Cycle 3 Day 1 at 1 hour, 4 hours, and 6 hours post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nelson Yee, MD principal investigator
Penn State Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBG/CBD Oil in people with Chemotherapy-Induced Peripheral Neuropathy, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Sowers (7175315471, psci-cto@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of CBG/CBD Oil (time frame: Through study completion (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.