Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

NCT05351801

Diabetic Neuropathic Pain Peripheral Neuropathic Pain

RECRUITING PHASE2

Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

NCT00068445

Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE3

Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

NCT01855607

Breast Cancer Colon Cancer Neuropathy

TERMINATED PHASE2

Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

NCT06121232

Neuropathy;Peripheral

ACTIVE_NOT_RECRUITING NA

Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer

NCT00281853

Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-Induced Peripheral Neuropathy Malignant Solid Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabidiol

Applied topically

Intervention Type DRUG

Placebo Administration

Applied topically

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CBD CBD Oil Epidiolex GWP42003-P Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)
* Alkaline phosphatase =\< 1.2 x ULN (following completion of chemotherapy)
* Serum creatinine =\< 1.2 x ULN (following completion of chemotherapy)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No