Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

NCT05388058 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC211003NCI-2022-0247921-011969
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Malignant Solid Neoplasm; Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Change in EORTC QLQ CIPN20 Motor Subscale From Baseline

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

• Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline

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

• Incidence of Adverse Events (AEs)

  Up to 14 days for each part of a sequence

• Incidence of Grade 3 or Higher Adverse Events

  Up to 28 days

Study Arms (2)

Arm I (cannabidiol, placebo)

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (placebo, cannabidiol)

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cannabidiol DRUG

Applied topically

Also known as: CBD, CBD Oil, Epidiolex, GWP42003-P

Arm I (cannabidiol, placebo); Arm II (placebo, cannabidiol)

Placebo Administration DRUG

Applied topically

Arm I (cannabidiol, placebo); Arm II (placebo, cannabidiol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (cannabidiol, placebo); Arm II (placebo, cannabidiol)

Questionnaire Administration OTHER

Ancillary studies

Arm I (cannabidiol, placebo); Arm II (placebo, cannabidiol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (9)

Mayo Clinic Health System Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Fairview Grand Itasca Clinic and Hospital

Grand Rapids, Minnesota, 55744, United States

Location

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

Location

Mayo Clinic Health System Mankato

Mankato, Minnesota, 56001, United States

Location

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

Location

Fairview Northland Medical Center

Princeton, Minnesota, 55371, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Sanford Thief River Falls

Thief River Falls, Minnesota, 56701, United States

Location

Sanford Worthington

Worthington, Minnesota, 56187, United States

Location

Related Publications (1)

• 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.

  PMID: 39016024 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Stacy D. D'Andre
• Organization: Mayo Clinic

dandre.stacy@mayo.edu

507-284-2511

Study Officials

• Stacy D. D'Andre, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 9, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 28, 2023
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2024-04

Locations

US (9)