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Cannabinoid

Topical Cannabidiol for Chemotherapy-Induced Peripheral Neuropathy

Phase 2

Waitlist Available

Led By Stacy D. D'Andre, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

Study Summary

This trial is testing whether cannabidiol cream can help relieve symptoms of chemotherapy-induced peripheral neuropathy, a type of nerve pain.

Who is the study for?

This trial is for adults over 18 with any cancer type who developed nerve pain or tingling from chemotherapy, stable on current neuropathy meds, if used. They must not be pregnant, nursing, or have skin issues where the cream would apply. No recent chemo (last 3 months) and no cannabis use within the last month.Check my eligibility

What is being tested?

The study tests if a cannabidiol cream can relieve nerve pain in hands/feet caused by chemotherapy compared to a placebo. Participants will also fill out questionnaires about their quality of life and symptoms during the trial.See study design

What are the potential side effects?

Potential side effects may include local skin reactions like redness or irritation at the site where the cream is applied. Since it's topical cannabidiol, systemic side effects are less likely but could include fatigue or changes in appetite.

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 have nerve pain or tingling from cancer treatment.

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My tests show no remaining cancer.

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My neuropathy pain or tingling is at least a 4 out of 10.

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

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My liver enzymes are within normal range after finishing chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in chemotherapy-induced peripheral neuropathy (CIPN)

Secondary outcome measures

Change in EORTC QLQ CIPN20 autonomic scale

Change in EORTC QLQ CIPN20 motor subscale

Incidence of adverse events

+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

38%

Tiredness

24%

Drowsiness

24%

Poor sleep

22%

Constipation

18%

Poor Appetite

16%

Dizziness

Headache

Diarrhea

Nausea

Itching

100%

80%

60%

40%

20%

Study treatment Arm

CBD Oil Group

Control Group

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (placebo, cannabidiol)Experimental Treatment4 Interventions

Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.

Group II: Arm I (cannabidiol, placebo)Experimental Treatment4 Interventions

Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

Placebo Administration

2018

Completed Phase 3

~2540

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,611 Total Patients Enrolled

14 Trials studying Peripheral Neuropathy

1,473 Patients Enrolled for Peripheral Neuropathy

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,110 Total Patients Enrolled

6 Trials studying Peripheral Neuropathy

354 Patients Enrolled for Peripheral Neuropathy

Stacy D. D'Andre, M.D.Principal InvestigatorMayo Clinic in Rochester

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05388058 — Phase 2

Peripheral Neuropathy Research Study Groups: Arm I (cannabidiol, placebo), Arm II (placebo, cannabidiol)

Peripheral Neuropathy Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05388058 — Phase 2

Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are presently enrolled in this research endeavor?

"Affirmative. The clinical trial is still accepting participants, as illustrated on the information found at clinicaltrials.gov - which was initially posted in June 9th 2022 and most recently updated in November 17th of that same year. It requires 40 individuals to be recruited from four different medical centres."

Answered by AI

What potential risks does Cannabidiol present to individuals using it?

"Our team at Power judged Cannabidiol's safety to be a 2, as this is only phase 2 of the clinical trial process and there are some data points demonstrating its safety but none yet indicating efficacy."

Answered by AI

Is enrollment still open for participants in this research?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical experiment is actively enrolling participants, having been initially posted on June 9th 2022 and most recently updated November 17th of the same year. Presently, 40 patients are being recruited from 4 distinct sites."

Answered by AI

How many locations in this city have been selected for the implementation of this research?

"Presently, 4 medical centres are enrolling patients for this trial. Thief River Falls, Mankato and Rochester are among the various spots available to join. Prospective enrollees should select the nearest site in order to reduce any potential travel obligations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

2022. "Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388058.

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