Clinical trial NCT05388058: Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Official title: Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: Baseline to end of week 2
Secondary outcomes:
measure: Change in EORTC QLQ CIPN20 motor subscale
timeFrame: Baseline to end of week 2
measure: Change in EORTC QLQ CIPN20 autonomic scale
timeFrame: Baseline to end of week 2
measure: Total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale
timeFrame: Up to 14 days
measure: Incidence of adverse events
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Mayo Clinic Health System Albert Lea
state: Minnesota
city: Grand Rapids
country: United States
facility: Fairview Grand Itasca Clinic and Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Medical Center
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health System Mankato
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Thief River Falls
country: United States
facility: Sanford Thief River Falls
state: Minnesota
city: Worthington
country: United States
facility: Sanford Worthington
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Stacy D. D'Andre, M.D.
role: PRINCIPAL_INVESTIGATOR
References: