Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cannabidiol

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