CBG/CBD Oil for Peripheral Neuropathy

Overseen By Wesley Raup-Konsavage, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Investigational drugs

Disqualifiers: Preexisting neuropathy, Uncontrolled hypertension, Thromboembolic event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a CBG/CBD oil to determine its safety and effectiveness in easing symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as pain and numbness, in individuals who have undergone certain gastrointestinal cancer treatments. Participants will take the oil under their tongue twice daily for 12 weeks. Researchers will assess its safety and participants' adherence to the regimen. They seek adults who have experienced CIPN symptoms for more than two weeks after completing chemotherapy for specific gastrointestinal cancers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you are currently taking any treatment for chemotherapy-induced peripheral neuropathy (CIPN), you must stop these treatments at least 2 weeks before joining the trial.

Is there any evidence suggesting that CBG/CBD oil is likely to be safe for humans?

Research has shown that CBG/CBD oil might be safe and well-tolerated for people experiencing nerve pain caused by chemotherapy. An early study found that taking 135 mg of CBD daily helped manage some symptoms without causing serious side effects.

While most studies focus on CBD alone, some evidence suggests that cannabinoids, in general, can reduce nerve pain in animals. These findings are promising, but more research is needed to confirm the safety of CBG/CBD oil for humans.

In this trial, participants will take a lower dose of CBG/CBD oil (33 mg of cannabinoids twice a day after the first week) for 12 weeks. The trial is in its early stages, aiming to assess the treatment's safety and tolerability. Regular safety checks will monitor any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for peripheral neuropathy, which often include medications like gabapentin or pregabalin that focus on symptom relief, the CBG/CBD oil uses cannabinoids derived from cannabis plants. This treatment is unique because it combines CBG (cannabigerol) and CBD (cannabidiol), which are thought to have anti-inflammatory and neuroprotective properties, potentially addressing the underlying causes of neuropathy rather than just alleviating symptoms. Additionally, the sublingual administration of this oil allows for fast absorption into the bloodstream, potentially offering quicker relief. Researchers are excited about this treatment as it opens the door to a novel approach for managing neuropathic pain, with the possibility of fewer side effects compared to traditional pharmaceuticals.

What evidence suggests that CBG/CBD oil might be an effective treatment for CIPN?

Studies have shown that CBG and CBD can help reduce nerve pain. Early research suggests these compounds may ease symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as pain and numbness. Some findings indicate that applying CBD oil to the skin can improve these symptoms. Cannabinoids might also enhance the effectiveness of chemotherapy while reducing its side effects. Overall, early evidence supports the potential of CBG/CBD oil to relieve CIPN symptoms. This trial will provide all participants with CBG/CBD oil treatment to further evaluate its safety, tolerability, and effectiveness in alleviating CIPN symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Nelson Yee, MD

Principal Investigator

Penn State Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults who have finished platinum-based chemotherapy for gastrointestinal cancers and are experiencing symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants must be willing to take CBG/CBD oil sublingually, attend study visits, complete symptom assessments, functional tests, and provide blood samples.

Inclusion Criteria

Agreement to use effective birth control or abstain from heterosexual activity

Patients from Penn State Health

I will stop any current treatments for nerve pain from chemotherapy 2 weeks before joining.

Exclusion Criteria

Recent use of investigational drugs or participation in another interventional investigational study

Known sensitivity to coconut oil

Pregnant and nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBG/CBD oil sublingually twice daily for 12 weeks, with the dose starting at 0.5 mL twice daily for the first week and increasing to 1 mL twice daily for the remaining 11 weeks. The treatment period is divided into three 4-week cycles.

12 weeks

Weekly remote safety phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up phone calls one month after the last dose.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBG/CBD Oil

Trial Overview The trial is testing if CBG/CBD oil can safely reduce CIPN symptoms over a 12-week period. It examines the tolerability of the oil when taken twice daily under the tongue and its effectiveness in managing pain and numbness associated with CIPN.

How Is the Trial Designed?

Group I: CBG/CBD Oil Treatment Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07016971

NCT07016971 | CBG/CBD Oil for Chemotherapy-Induced ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/cbg-cbd-oil-for-chemotherapy-induced-peripheral-neuropathy

CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy The study is based on preclinical findings from Dr. Wesley Raup-Konsavage's laboratory, which showed that CBG and CBD reduced neuropathic pain ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31793418/

The Effectiveness of Topical Cannabidiol Oil in ... Our findings demonstrate that the transdermal application of CBD oil can achieve significant improvement in pain and other disturbing sensations in patients ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-cbg-cbd-oil-chemotherapy-induced-peripheral-neuropathy-trial-nct07016971

CBG/CBD Oil for Chemotherapy-Induced Peripheral ... Benefits: Participation may help reduce neuropathic pain, numbness, and other symptoms associated with chemotherapy-induced peripheral neuropathy (CIPN). The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0163725825000634

Effect of cannabinoids on the efficacy and side ... The data available to date raise the prospect that cannabinoids may increase the efficacy of chemotherapeutic agents while reducing their side effects.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12020

Safety and efficacy of cannabidiol in the management ... This preliminary study provides evidence that CBD, dosed at 135 mg/day, might serve as a treatment for some CIPN symptoms without serious adverse events.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8646190/

Topical Cannabinoids for Treating Chemotherapy-Induced ... This case series suggests that topical cannabinoids may be helpful for patients with chemotherapy-induced peripheral neuropathy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923007055

Cannabinoids: an Effective Treatment for Chemotherapy ... In animal models, cannabinoids suppress neuropathic pain induced by traumatic nerve injury, toxic insults, and metabolic changes [32], although the role of ...

9. ccjm.org ccjm.org/content/85/12/943

Cannabis for peripheral neuropathy: The good, the bad, ... Most studies show moderately improved pain from inhaled cannabis use, but adverse effects such as impaired cognition and respiratory problems are common, ...