What side effects are associated with this type of intervention?

Common treatments for Peripheral Neuropathy, particularly those involving cannabinoids like CBD and THC, can have several side effects. These may include dizziness, dry mouth, fatigue, and changes in appetite or weight. Some patients may also experience mood changes, such as anxiety or euphoria. Additionally, there can be cognitive effects like impaired memory and concentration. It's important to note that while these treatments can help manage pain and inflammation, they may not be suitable for everyone, especially those with a history of substance use disorders.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of neuropathic pain, though specific approvals for peripheral neuropathy using phytocannabinoids like CBD and THC are not mentioned. Nabiximols, an oromucosal spray containing THC and CBD, has shown some efficacy in treating neuropathic pain and is approved in several countries outside the United States. Other cannabinoid-based treatments, such as dronabinol and nabilone, are available for various indications but not specifically for peripheral neuropathy. These treatments work by modulating the endocannabinoid system to reduce pain and inflammation.

What other types of research exist?

Promising novel alternatives to phytocannabinoids for peripheral neuropathy include: 1) N-acetylcysteine (NAC) - an antioxidant that reduces oxidative stress and inflammation; 2) Gabapentin - a GABAergic agent that modulates neurotransmission to alleviate neuropathic pain; 3) Capsaicin - a topical agent that depletes substance P, reducing pain signaling; 4) Botulinum toxin A - reduces pain by inhibiting neurotransmitter release; 5) N,N-dimethylglycine (DMG) - a metabolic enhancer that may improve cellular function and reduce symptoms.

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Cannabinoid

Cannabis for Peripheral Neuropathy

Q: What is the mechanism of action of this treatment?

Peripheral neuropathy treatments often target the underlying mechanisms of nerve pain and inflammation. Phytocannabinoids like CBD and THC modulate the endocannabinoid system, which plays a role in pain perception and inflammation. By activating cannabinoid receptors (CB1 and CB2), these compounds can reduce pain and inflammation, potentially offering relief for neuropathy patients. This is particularly relevant for those with chemotherapy-induced peripheral neuropathy (CIPN), where traditional treatments may be insufficient. Understanding these mechanisms helps in tailoring more effective pain management strategies for neuropathy patients.

Phase < 1

Waitlist Available

Led By Richard T Lee

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: >= 18 years

Eastern Cooperative Oncology Group (ECOG) =< 2

Must not have

Clinically significant uncontrolled illness

Diagnosis of Gilbert's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial tests whether cannabis compounds CBD and THC can reduce nerve pain in breast and colon cancer survivors who have pain from chemotherapy. These compounds may help by affecting how the body processes pain signals. An oral spray containing cannabinoids has shown promise in early studies for reducing chemotherapy-related nerve pain.

Who is the study for?

This trial is for breast and colon cancer survivors over 18, with chronic neuropathy from chemotherapy that included taxane or platinum. They must be able to read English, not pregnant, willing to use birth control, and have no recent medical cannabis use or plans for new cancer treatments during the study.

What is being tested?

The trial tests if phytocannabinoids (CBD and THC) can reduce chronic neuropathy pain in cancer survivors. Participants will receive either these substances or a placebo while their symptoms are monitored through questionnaires.

What are the potential side effects?

Potential side effects may include changes in mood or perception due to THC's psychoactive properties, digestive issues like nausea or loss of appetite from both CBD and THC, fatigue, dizziness, dry mouth, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have moderate to severe nerve pain or damage.

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My neuropathy was caused by chemotherapy with taxane or platinum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled serious illnesses.

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I have been diagnosed with Gilbert's disease.

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I am not pregnant or breastfeeding.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I am not using alternative medicines like medical cannabis, herbs, or high-dose vitamins.

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I haven't changed my CIPN medication in the last 4 weeks.

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My liver condition is severe (Child-Pugh B or C).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores

Secondary study objectives

Incidents of adverse events

Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) scores

Utilization of neuropathic and pain medications

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm II (CBD + THC)Experimental Treatment3 Interventions

Patients receive CBD PO + THC PO on study.

Group II: Arm I (CBD)Experimental Treatment2 Interventions

Patients receive CBD PO on study.

Group III: Arm III (placebo)Placebo Group2 Interventions

Patients receive placebo PO on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral neuropathy treatments often target the underlying mechanisms of nerve pain and inflammation. Phytocannabinoids like CBD and THC modulate the endocannabinoid system, which plays a role in pain perception and inflammation. By activating cannabinoid receptors (CB1 and CB2), these compounds can reduce pain and inflammation, potentially offering relief for neuropathy patients. This is particularly relevant for those with chemotherapy-induced peripheral neuropathy (CIPN), where traditional treatments may be insufficient. Understanding these mechanisms helps in tailoring more effective pain management strategies for neuropathy patients.

Clinical trials of diabetic neuropathy: past, present, and future.