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Cannabinoid

Cannabis for Peripheral Neuropathy

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
Awards & highlights

Summary

This trial is testing how well cannabis can reduce chronic pain from chemotherapy in cancer survivors. It may provide relief with fewer risks than existing treatments.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
575 Previous Clinical Trials
1,922,586 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,281 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Richard T LeePrincipal InvestigatorCity of Hope Medical Center

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05672342 — Phase < 1
Peripheral Neuropathy Research Study Groups: Arm I (CBD), Arm II (CBD + THC), Arm III (placebo)
Peripheral Neuropathy Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05672342 — Phase < 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672342 — Phase < 1
~80 spots leftby Oct 2025