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Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT05388058

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

A Phase 2 study testing Cannabidiol, Quality-of-Life Assessment and Questionnaire Administration in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Solid Neoplasm, run by Mayo Clinic at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cannabidiol, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
9 sitesUnited States
Study dates
9 Jun 2022to 28 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years
  • English speaking
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy
  • At least 4 out of 10 severity of neuropathy pain and/or tingling
  • Stable for at least 7 days prior to registration on medications for neuropathy, if any are being used
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Show all 17Show fewer
  • Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
  • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Able to provide written informed consent
  • Ability to complete questionnaire(s) by themselves or with assistance
  • No evidence of residual cancer
  • Platelet count > 100,000/mm^3 (following completion of chemotherapy)
  • Absolute neutrophil count (ANC) >= 1,000/mm^3 (following completion of chemotherapy)
  • Hemoglobin > 11 g/dL (following completion of chemotherapy)
  • Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN) (following completion of chemotherapy)
  • Alkaline phosphatase =< 1.2 x ULN (following completion of chemotherapy)
  • Serum creatinine =< 1.2 x ULN (following completion of chemotherapy)

Who cannot join

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential who are unwilling to employ adequate contraception
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Show all 10Show fewer
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months
  • Use of other cannabis products within 30 days prior to registration
  • History of allergy to cannabis products

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Mayo Clinic Health System Albert Lea

    Albert Lea, Minnesota, 56007

  • Fairview Grand Itasca Clinic and Hospital

    Grand Rapids, Minnesota, 55744

  • Fairview Range Medical Center

    Hibbing, Minnesota, 55746

  • Mayo Clinic Health System Mankato

    Mankato, Minnesota, 56001

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Sanford Thief River Falls

    Thief River Falls, Minnesota, 56701

  • Sanford Worthington

    Worthington, Minnesota, 56187

Other trials in United States

About this study

Official title: Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial

This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate whether topical cannabidiol (CBD) improves CIPN, compared to placebo.

II. To evaluate side effects from topical CBD cream use, compared to placebo.

SECONDARY OBJECTIVES:

  1. Other measures of neuropathy as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN20 motor subscale, the EORTC QLQ CIPN20 autonomic scale, and the total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale.

II. Adverse event profiles will also be assessed using symptom questionnaires and CTCAE version (v)5.0.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply cannabidiol cream topically to affected areas twice daily (BID) for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.

ARM II: 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.

Being tested
Cannabidiol, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabidiolDrug

    Also called CBD, CBD Oil, Epidiolex, GWP42003-P

    Applied topically

  • Placebo AdministrationDrug

    Applied topically

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05388058
Study groupRoleWhat they receive
Arm I (cannabidiol, placebo)ExperimentalPatients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Receives: Drug: Cannabidiol; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (placebo, cannabidiol)ExperimentalPatients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
Receives: Drug: Cannabidiol; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline

    CIPN will be measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 which is composed of 9 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms.

    Measured: Week 1, week 2, week 3, and week 4

Secondary outcomes (4)

  1. Change in EORTC QLQ CIPN20 Motor Subscale From Baseline

    Motor symptoms of CIPN will be measured by the motor subscale of the EEORTC QLQ-CIPN20 which is composed of 8 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.

    Measured: Week 1, week 2, week 3, and week 4

  2. Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline

    Autonomic nervous system symptoms related to CIPN will be measured by the autonomic subscale of the EEORTC QLQ-CIPN20 which is composed of 3 individual items answered on a 4-point scale ranging from "not at all' to "very much." . Higher scores indicate more severe symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.

    Measured: Week 1, week 2, week 3, and week 4

  3. Incidence of Adverse Events (AEs)

    Incidence of AEs will be reported per arm, assessed using Common Terminology Criteria (CTCAE) version 5.0.

    Measured: Up to 14 days for each part of a sequence

  4. Incidence of Grade 3 or Higher Adverse Events

    Will be assessed using symptom questionnaires and CTCAE version 5.0. Will compare the maximum (worst) values between arms. Fisher's exact tests will be used to compare incidence rates and Wilcoxon rank-sum tests will be used to compare maximum values between arms.

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start9 Jun 2022
  3. Primary completion14 Jul 2023
  4. Study completion28 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388058
Sponsor's protocol ID
MC211003
Other IDs
NCI-2022-02479, 21-011969
Status last verified
Apr 2024
First submitted
19 May 2022
Last updated
16 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • D'Andre S, Novotny P, Walters C, Lewis-Peters S, Thome S, Tofthagen CS, Giridhar KV, Loprinzi C. Topical Cannabidiol for Established Chemotherapy-Induced Neuropathy: A Pilot Randomized Placebo-Controlled Trial. Cannabis Cannabinoid Res. 2024 Dec;9(6):e1556-e1564. doi: 10.1089/can.2023.0253. Epub 2024 Jul 17.

    PubMed 39016024

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol, Quality-of-Life Assessment and Questionnaire Administration in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Solid Neoplasm, run by Mayo Clinic at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline (time frame: Week 1, week 2, week 3, and week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388058, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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