Status:
COMPLETED
Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Mayo Clinic
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 neuropa...
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 OBJE...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05388058
Start Date
June 9 2022
End Date
July 28 2023
Last Update
April 26 2024
Active Locations (9)
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1
Mayo Clinic Health System Albert Lea
Albert Lea, Minnesota, United States, 56007
2
Fairview Grand Itasca Clinic and Hospital
Grand Rapids, Minnesota, United States, 55744
3
Fairview Range Medical Center
Hibbing, Minnesota, United States, 55746
4
Mayo Clinic Health System Mankato
Mankato, Minnesota, United States, 56001