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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study 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 belowSelect...
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.
Select...
I have moderate to severe nerve pain or damage.
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My neuropathy was caused by chemotherapy with taxane or platinum.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
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
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,340 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,547 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled serious illnesses.I have been diagnosed with Gilbert's disease.I am not pregnant or breastfeeding.I am 18 years old or older.I am capable of having children and have not been surgically sterilized.I am not taking strong CYP3A4 inhibitors or inducers.I can take care of myself and am up and about more than 50% of my waking hours.Your alanine aminotransferase (ALT) levels should be less than or equal to three times the upper limit of normal (ULN).I am willing to follow all study requirements, including using medical cannabis.I am not using alternative medicines like medical cannabis, herbs, or high-dose vitamins.You have used medical cannabis for any reason in the 30 days before the study starts.I haven't changed my CIPN medication in the last 4 weeks.My liver condition is severe (Child-Pugh B or C).I have a history of chronic neuropathy due to diabetes, HIV, or other causes.Your AST blood test result is not more than 3 times the upper limit of normal.I am not currently undergoing, nor have I had chemotherapy, radiation, or surgery in the last 3 months. Hormonal therapy is okay.I have moderate to severe nerve pain or damage.My neuropathy was caused by chemotherapy with taxane or platinum.Your total bilirubin level is not more than 1.5 times the upper limit of normal, unless you have Gilbert's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (CBD)
- Group 2: Arm II (CBD + THC)
- Group 3: Arm III (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could individuals with the designated condition participate in this experiment at present?
"Clinicaltrials.gov lists this trial as no longer recruiting, as the posting date of 6th June 2023 and latest update on 3rd January 2023 testify to. However, there are plenty of other medical trials actively seeking patients at present - over 4500 such opportunities exist currently."
Answered by AI
Who else is applying?
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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