Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05388058
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05388058
Study Brief:
Protocol Section:
NCT05388058