Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

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.

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