Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Mayo Clinic40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Mayo Clinic Health System Albert Lea

Albert Lea, Minnesota, United States

Fairview Grand Itasca Clinic and Hospital

Grand Rapids, Minnesota, United States

Fairview Range Medical Center

Hibbing, Minnesota, United States

Mayo Clinic Health System Mankato

Mankato, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Sanford Thief River Falls

Thief River Falls, Minnesota, United States

Sanford Worthington

Worthington, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 1, week 2, week 3, and week 4

Secondary Outcomes

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.

Time frame: Week 1, week 2, week 3, and week 4

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.

Time frame: Week 1, week 2, week 3, and week 4

Incidence of Adverse Events (AEs)

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

Time frame: Up to 14 days for each part of a sequence

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.

Time frame: Up to 28 days

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes